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

Intended use: api® 20 a is a qualitative standardized system for the identification of anaerobes.It uses miniaturized tests as well as a specially adapted database.Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software.Issue description: a customer in the united states notified biomérieux of obtaining a misidentification result in association with the product api 20 a 25strips+25media (ref.20300, lot 1008569360, expiration date = 10-jul-2022) when testing a cap survey strain.The customer stated lot 1008569360 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.An investigation has been performed.

Manufacturer Narrative

A customer in the united states notified biomérieux of obtaining a misidentification result in association with the product api 20 a 25strips+25media (ref.20300, lot 1008569360, expiration date = 10-jul-2022) when testing a cap survey strain.The investigation results are the following: 1.Retained samples analysis the retained sample for the reported lot number 1008247410 (additional api 20 a lot reported for the same issue) was tested in parallel with one internal lot number used as reference.The tests were performed using the quality control (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 for the two api 20 a lots tested.2.Analysis of the strain provided.Tests were performed with the cap survey prevotella melaninogenica strain provided for the investigation.The identification of the strain received was confirmed in-house with vitek® ms as prevotella melaninogenica.The cap survey strain was tested with the two (2) following api 20 a lots : lot 1008247410 and a reference lot 1008024290.The investigation obtained a very good identification to prevotella bivia (99.4%) for both lots, reproducing the identification described by the customer.In the api 20 a knowledge base, only three tests are discriminating between prevotella melaninogenica and prevotella bivia.The concerned tests are sac, raf and gly.- negative results for sac and raf tests were obtained by the customer, and were reproduced during the investigation.- positive results for gly test were obtained by the customer, and a doubtful result (¿?¿) during the investigation.The following percentages 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 for these 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.3.Batch record analysis.No non-conformity during manufacturing and quality control processes were observed for the lot numbers 1008247410 and 1008569360.4.Complaint trend analysis on the 27th october 2021, a complaint trending analysis was performed on the lot numbers 1008247410 and 1008569360.No other complaints related to the same issue were registered for these two lot numbers.Furthermore, since 2018, the complaint trending analysis does not show performance issue on the product api® 20 a, reference 20300.5.Final conclusion the results of quality control obtained during our investigation on the impacted product api® 20 a, reference 20300, lot 1008247410 complied with specifications.The batch records analysis does not show non-conformity during manufacturing and quality control processes for the lot numbers 1008247410 and 1008569360.The trend analysis of the complaints does not show any deviation on the product api® 20 a, reference 20300.The identification to prevotella bivia was reproduced with the cap survey strain provided during our investigation.The identification to prevotella bivia instead of prevotella melaninogenica is due to the biochemical profile of the cap survey prevotella melaninogenica strain that is atypical (negative results for 2 discriminant tests, sac and raf, instead of positive results, and positive result for discriminant test gly instead of negative result).The results obtained are more in accordance with prevotella bivia but they also could be observed for some prevotella melaninogenica strains.They nevertheless do not represent the majority of the cases for this species.The discrimination of the two species is a challenge, and the profiles of the two species interesting; therefore, we will study the technical options available for a potential evolution of the api 20 a knowledge base.The investigation has been completed; nevertheless complaint trend analysis for this reference will continue to be monitored.

• 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
• MDR Report Key: 12706289
• MDR Text Key: 284692268
• Report Number: 9615754-2021-00276
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026048150
• UDI-Public: 03573026048150
• 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
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 1008569360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1