MAUDE Adverse Event Report: BIOMERIEUX SA API 50 CH 10STRIPS - 50300

Catalog Number 50300

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

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

Event Type  malfunction  

Event Description

On the 13th of april 2021, a customer from (b)(6) reported to biomérieux that they have obtained a potential false positive result with the product api 50 ch 10strips (ref 50300, batch 1008511380, expiry date 13-oct-2021).The customer said he observed orange coloration post-incubation even in the absence of bacteria.It was reported that the customer tested api 50 ch with aerobic and anaerobic organisms.He read at 24/48 and 72 hours for aerobic organisms and 48/72 hours for anaerobic organisms, and results were the same with and without bacteria.The methodology was confirmed, mcf is acceptable as indicated in the technical sheet, use of the densimat storage ok 2/8 °c.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.

Manufacturer Narrative

A customer in france notified biomérieux of obtaining an orange color for all tests that appeared after incubation when testing api 50 ch strips, reference 50300, lot number 1008511380 (expiry date 13 oct 2021).Api® 50 chb medium, reference 50430, lot 1008427970, was also used to perform the test.The customer stated that the tests were performed without strains in the api® 50 chb medium and the strip also turned an orange color.Photographs were provided for the investigation.Investigation.Retained samples analysis: biomérieux retains samples of every lot number released to the market.Retained samples for the impacted lot were tested in association with the api 50 chb medium, reference 50430, lot 1008427970 that was used to perform the test.In parallel, tests were also performed with the following lot numbers used as reference lots, api 50 ch lot number 1008656310 and api 50 chb medium lot number 1008216180.Bacteriological tests were performed using the quality control (qc) strains klebsiella pneumoniae ssp pneumoniae atcc® 35657¿ and paenibacillus polymyxa atcc® 43865¿ according to the qc protocol used for the release of each lot number.Tests were also performed without strains and incubated for 72 hours.These tests were performed with and without paraffin oil.The qc results obtained for the two strains tested are in accordance with the expected specifications for the impacted lot and the reference lot tested.The tests performed without strains did not show an orange color for the api 50 ch tests, neither for the impacted lot nor the reference lot tested at 72 hours of incubation.The results were the same for all the strips tested with and without paraffin oil; an orange color was not observed.The investigation did not reproduce the reported issue.Complaint review.The investigator reviewed the records in the complaints database to search for similar issues related to the lot numbers provided - 1008511380 (api 50 ch) and 1008427970 (api 50 chb medium).No other complaints were registered on these lot numbers for this type of issue.Conclusion.The results of quality controls obtained during our investigation complied with specifications both for bacteriological tests and for tests performed without strains.The investigation therefore did not reproduce the issue observed by the customer.The investigator did not find any deviations in product performance.The customer suspected that the orange color was possibly due to incorrect product storage (long time at room temperature).Biomérieux reiterated the importance of using the correct storage conditions for the product.As described in the package insert, store the strips at 2-8°c until the expiration date indicated on the packaging.As the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.Complaints will continue to be monitored on this reference.

• Brand Name: API 50 CH 10STRIPS - 50300
• Type of Device: API 50 CH 10STRIPS - 50300
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11809115
• MDR Text Key: 281406846
• Report Number: 9615754-2021-00159
• Device Sequence Number: 1
• Product Code: JSC
• UDI-Device Identifier: 03573026087401
• UDI-Public: 03573026087401
• 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,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Catalogue Number: 50300
• Device Lot Number: 1008511380
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1