MAUDE Adverse Event Report: BIOMERIEUX S.A. ID COLOR CATALASE 2X5 ML; ID COLOR CATALASE 2X5 ML - 55561

Catalog Number 55561

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of false positive results in association with id color catalase (ref.55561, lot: 1007205060).The customer tested atcc® 29212¿ enterococcus faecalis and an unknown number of patient enterococcus faecalis and streptococci strains with lot:1007205060.The number of patient strains impacted was not provided.The customer stated the false positive catalase result caused the incorrect vitek® 2 cards to be used for antibiotic susceptibility testing (ast) leading to a delay in obtaining ast results.The customer also tested the isolates using lot 1007568120; false positive results were also obtained.There is no indication or report from the laboratory that the false positive result led to any adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in germany regarding false positive results in association with id color catalase (ref.55561, lot 1007205060).The customer tested atcc® 29212¿ enterococcus faecalis and an unknown number of patient enterococcus faecalis and streptococci strains with lot 1007205060.Production file reviews revealed the lot conformed with specifications for all quality controls tested.Nonconformances and deviations were not detected on this lot number.Retained sample of the impacted lot was tested in parallel with a reference lot (1007812580) with the following atcc strains: s;aureus atcc 25923, s.Epidermidis atcc 12228, listeria monocytogenes atcc 19115, e.Faecalis atcc 29212, and streptococcus group a atcc 86687.All the results obtained conformed with the specifications of the lot.Nonconformance or discrepant results were not obtained.The issue of the customer was not reproduced.No similar customer complaints have been been received on this lot.See section h10.

• Brand Name: ID COLOR CATALASE 2X5 ML
• Type of Device: ID COLOR CATALASE 2X5 ML - 55561
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 10678758
• MDR Text Key: 229934225
• Report Number: 9615755-2020-00021
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026092009
• UDI-Public: 03573026092009
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Catalogue Number: 55561
• Device Lot Number: 1007205060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1