Alerta De Seguridad para NON-SPECIFIC SYSTEMS FOR GLYCOSIS - DEVICES FOR MEASURING AND REAGENT RAYS OF GLYCOSYDIDROGENASE WITH PYRROLOQUINONE QUINONE (GDH-PQQ) OR MUT Q-GDH. [ALERT UPDATED ON 07/09/2015]. [ALERT UPDATED ON 08/17/2015]. [ALERT UPDATED ON 08/26/2015].

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Reactive ribbons based on the enzyme Pyrroloquinone Dehydrogenase Pyrroloquinone Quinone (GDH-PQQ) may lead to false high glucose concentration results in blood samples containing certain sugars other than glucose (maltose, xylose or galactose, for example), given low selectivity for glucose. Mutant variations of GDH-PQQ (mut. Q-GDH) may also undergo galactose interference, which may lead to falsely elevated glucose results in the same way. False high glucose results may lead to an incorrect diagnosis of hyperglycaemia and, sequentially, inappropriate dosing / administration of insulin to the patient, leading to hypoglycemia, coma, or death. False high glucose results can also mask true hypoglycemia. Galactosemia is a metabolic deficiency that causes an increased concentration of galactose in the blood. There is no conclusive study on the frequency of galactosemia in Brazil as a whole; however, a pilot study conducted in the state of São Paulo with 59,953 newborns (10% of all live births in 2006) has identified an incidence of galactosemia of around 1: 20,000 newborns. According to references cited in this study, estimates of the frequency of galactosemia in the world are variable - between 1: 100,000 (Asia) and 1: 14,000 (South Africa). The use of reagent tapes based on GDH-PQQ, or mut Q-GDH, on blood samples from patients with galactosemia may lead to misdiagnosis of high glucose and consequent serious adverse events resulting from inappropriate insulin administration. The risk of serious adverse events may be even greater in the case of neonates with galactosemia, due to the low communication capacity of these patients. In addition, newborns are not routinely tested for galactosemia soon after birth - the test for this alert supplements earlier warning information regarding GDH-PQQ technology, published in 2009: Technovigilance Alert # 992, available at http: //www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;=992. Other important references: See field SOURCE of this alert. [ALERT UPDATED ON 07/09/2015]. [ALERT UPDATED ON 08/17/2015]. [ALERT UPDATED ON 08/26/2015].