MAUDE Adverse Event Report: BIOMÉRIEUX, SA API 20 A 25STRIPS+25MEDIA; API® 20 A 25STRIPS+25MEDIA

Model Number	20300
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the (b)(6) notified biomérieux of a misidentification of clostridium bifermentans as clostridium perfringens while testing an external proficiency survey sample with the api® 20 a 25strips+25media (ref 20300, lot 1007917630).According to the proficiency survey report, the sample actually contained clostridium bifermentans at a level of 1950 cfu/g.The profile obtained by the customer was (b)(4) which gave an identification of clostridium perfringens at 99% excellent id.As this was an external proficiency survey sample, there is no patient involved.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united kingdom regarding a misidentification of clostridium bifermentans as clostridium perfringens while testing an external proficiency survey sample with the api® 20 a 25strips+25media (ref 20300, lot 1007917630).A review of all data registered for the manufacturing and control departments of the lot 1007917630 did not highlight any issues related to the customer¿s complaint.Quality control strains (three from the package insert) were tested on the retain lot of 1007917630, and also on a reference lot (1008024290).The results complied with specifications for both lots.No identification issue was observed on the impacted lot number 1007917630 with the clostridium bifermentans atcc® 638¿ tested.The profile gave a "very good identification to genus" with clostridium bifermentans in the choices.The customer¿s "excellent identification" to clostridium perfringens was not reproduced.The api® 20 a batch (reference (b)(4) batch 1007917630) is not defective.A potential root cause could be a contamination by the staphylococcus aureus strain included in the lgc sample when the customer inoculated the clostridium bifermentans strain on the api® 20 a strip.See section h10.

• Brand Name: API 20 A 25STRIPS+25MEDIA
• Common Device Name: API® 20 A 25STRIPS+25MEDIA
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10680336
• Report Number: 9615754-2020-00159
• Device Sequence Number: 3313098
• Product Code: JSP
• UDI-Device Identifier: 03573026048150
• UDI-Public: 03573026048150
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/05/2021

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: 08/04/2021
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 1007917630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1