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

Catalog Number	55561
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from germany notified biomérieux of false positive results in association with id color catalase (ref.55561, lot 1007568120).The customer tested atcc® 29212¿ enterococcus faecalis and an unknown number of patient enterococcus faecalis and streptococci strains with lot 1007568120.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 1007205060; 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.
Additional 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 1007568120).The customer tested atcc® 29212¿ enterococcus faecalis and an unknown number of patient enterococcus faecalis and streptococci strains with lot 1007568120.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.There have been no similar complaints for this lot number.See section h10.

• Brand Name: ID COLOR CATALASE 2X5 ML
• Common Device Name: ID COLOR CATALASE 2X5 ML
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 10678878
• Report Number: 9615755-2020-00022
• Device Sequence Number: 3000079
• Product Code: JTO
• UDI-Device Identifier: 03573026092009
• UDI-Public: 03573026092009
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2021
• Device Catalogue Number: 55561
• Device Lot Number: 1007568120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1