Alerta De Seguridad para CoaguChek XS Pro

Safety alert

2013-02-19

2013-02-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130219b.html

Medical device safety alert: roche coaguchek xs pro medical device manufacturer, roche diagnostics gmbh issued a medical device safety alert concerning an issue with erroneous decoding of ean 13 barcodes used on coaguchek xs pro. roche explained that for ean 13, iso/iec 15420 is applicable. there are 10 sizes (sc0…sc9) are specified in iso/iec 15420, with a“standard size’’ sc2 = 100%. the smallest specified symbol size (class sc0, 81.8%) is 30.50 x 21.48 mm with a module width of 0.27mm. the barcodes on the wrist bands of a customer in europe were only at approximately 49% of the sc2 standard size. on the other hand, the quality of the barcodes was found to have some deficiencies as regards correctness of guard bar and other width patterns. therefore, some ean 13-coded patient ids on wrist bands were intermittently decoded erroneously. roche will further assess further possibilities to reduce the probability of occurrence for this issue by modification to the barcode security level scanner settings. users are suggested to: ensure size and quality of barcodes used follow the applicable standards for all barcode types. avoid using ean 13 barcode types for patient and operator identification as far as possible. according to the local supplier, roche diagnostics (hong kong) limited, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2013.