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

Model Number 20300

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of obtaining a misidentification result in association with the api® 20 a (ref.20300, lot 1008247410) when testing a cap survey strain.The customer stated lot 1008247410 identified the isolate as prevotella bivia, and confirmed the expected result for the survey strain was prevotella melaninogenica.The customer repeated testing and the same misidentification result was obtained.Biomérieux customer service has requested the cap survey strain as well as customer methodology and troubleshooting information.As there is no patient associated with this survey strain, there is no adverse event related to any patient's state of health.Biomerieux has initiated an internal investigation.

Manufacturer Narrative

A customer in the united states notified biomérieux of obtaining a misidentification result in association with the api® 20 a (ref.(b)(4), lot 1008247410) when testing a cap survey strain.Investigation: review of the complaints database revealed no other complaints related to the same issue with the customer¿s lot number.Testing: a retained sample from the impacted lot number (1008247410) was tested in parallel with one internal lot number used as reference (1008024290).The tests used the qc strains bacteroïdes ovatus atcc® 8483¿, clostridium perfringens atcc® 13124¿ and clostridium sordellii atcc® 9714¿ mentioned in the package insert 07882 version i.The qc results obtained for the three strains tested are in accordance with the expected specifications.The identification of the strain received was confirmed in-house with vitek ms as prevotella melaninogenica.In the api 20 a knowledge base, only three tests discriminate between prevotella melaninogenica and prevotella bivia.The concerned tests are sac, raf and gly.Negative results for sac and raf tests were obtained and the investigation reproduced the same results for these two tests.Positive results for gly test were obtained and the investigation obtained a doubtful result (¿?¿).The following are mentioned in the api 20 a knowledge base : sac test: 0% for prevotella bivia and 83% for prevotella melaninogenica; raf test: 0% for prevotella bivia and 89% for prevotella melaninogenica; gly test: 80% for prevotella bivia and 18% for prevotella melaninogenica.The results obtained during the investigation on those three tests are more in accordance with prevotella bivia.Such results can nevertheless be observed for some prevotella melaninogenica strains but they remain in the minority of this species.The results of quality control obtained during our investigation on the impacted product api® 20 a, reference (b)(4), lot 1008247410 complied with specifications.The batch records analysis does not show any non-conformities during manufacturing and quality control processes (lot #1008247410).The trend analysis of the complaints does not show any deviation on the product api® 20 a, reference (b)(4).Conclusion: the root cause of this customer¿s issue is the atypical results obtained using the cap survey strain; negative results for two (2) discriminant tests, sac and raf, instead of positive results and positive result for discriminant test gly instead of negative result.

• Brand Name: API® 20 A 25STRIPS+25MEDIA
• Type of Device: API® 20 A 25STRIPS+25MEDIA
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11873537
• MDR Text Key: 252366737
• Report Number: 9615754-2021-00168
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026048150
• UDI-Public: 03573026048150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2021
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 1008247410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1