MAUDE Adverse Event Report: BIOMERIEUX SA API 20 E; API 20 E 25STRIPS - 20100

Catalog Number	20100
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 (b)(6) notified biomérieux of obtaining no identification result when testing internal qc strains with the api® 20 e (ref 20100, lot 1007437810).The issue was observed during a training session with qc strains.As this was a training session with qc strains, there is no patient involved.The customer reported that tubes on the api® 20 e strips dried out and no result could be obtained.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of obtaining no identification result when testing internal qc strains with the api® 20 e (ref 20100, lot 1007437810).The customer reported that tubes on the api® 20 e strips dried out and no result could be obtained.Investigational testing included testing atcc® quality control strains with retained kits from the customer's lots (1007437810) and an internal reference lot (1007546490).Atcc® 25922¿ escherichia coli atcc® 13047¿ enterobacter cloacae atcc® 35659¿ proteus mirabilis atcc® 35657¿ klebsiella pneumonia spp pneumonia atcc® 51331¿ stenotrophomonas maltophilia in addition, testing was performed to assess if the issue of dehydration could be linked to the incubation boxes provided with the strips.The atcc® 25922¿ escherichia coli strain was tested with the strip of the reference lot 1007546490 but mixing the incubation boxes (incubation boxes of the two impacted lots in parallel with the incubation box of the reference lot).No dehydration has been observed on the lots tested.The customer¿s issue is then not reproduced in house.Qc strains profiles are in agreement to the expected theoretical profiles therefore api® 20e is within its expected level of specifications.See h10 for addtl mfg narrative.

• Brand Name: API 20 E
• Common Device Name: API 20 E 25STRIPS - 20100
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes 38390 ; FR 38390
• MDR Report Key: 9527462
• Report Number: 9615754-2019-00145
• Device Sequence Number: 10877623
• Product Code: JSS
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• 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): 04/21/2020

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: 12/02/2020
• Device Catalogue Number: 20100
• Device Lot Number: 1007437810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1