MAUDE Adverse Event Report: BIOMERIEUX SA ID 32 STAPH 25STRIPS - 32500

Catalog Number 32500

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

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

Event Date 05/06/2021

Event Type  malfunction  

Event Description

Product intended use: id 32 staph is a qualitative standardized system for the identification of the genera staphylococcus, micrococcus and related genera, rothia and aerococcus.It uses miniaturized tests as well as a specially adapted database.After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.Description of the issue: a customer from (b)(6) reported that api® strip id 32 staph (ref.32500, lot 1008439200) did not work correctly during reading with apiweb¿ (identification software).The customer reported that on (b)(6) 2021, multiple reagent strips displayed incorrect information on the system, and bacterial identification could not be performed.No details were provided regarding the incorrect information displayed; however, in the worst case scenario, an incorrect organism identification can be suspected.There is no indication from the customer that this event led to a delay of result or impacted the patient state of health.The customer indicated he reported this incident to (b)(6).

Manufacturer Narrative

A customer from china notified biomérieux that multiple api® strips id 32 staph (ref.32500; lot# 1008439200) displayed incorrect information on the system and bacterial identification could not be performed.Investigation the retained sample for the impacted lot (#1008439200) was tested in parallel with an internal lot number 1008545970 used as reference.Tests were performed using the quality control (qc) strains staphylococcus lugdunensis atcc® 49576¿, staphylococcus aureus atcc® 29213¿ and staphylococcus gallinarum atcc® 700401¿ mentioned in the package insert 08020 version g.All the qc results obtained with the three atcc® strains are in accordance with the expected specifications for the two id 32 staph lots tested.A visual reading and an automatic reading were realized with the strips tested, and all strips tested were recognized correctly during the reading step.Lot history the investigator reviewed the manufacturing documentation for the customer¿s lot (#1008439200).Non-conformities during manufacturing and quality control processes were not found.On the 31st august 2021, the investigator searched biomérieux¿s complaint records for similar reports or other issues occurring on the same lot (1008439200).No other reports for this lot number have been received.Furthermore, the investigator did not find any evidence of systemic nor quality control issues that could be linked with the customer¿s report.Conclusion no issue was observed related to the recognition of the strips by the automate.The results of quality control tests obtained during our investigation on the impacted product (id 32 staph, reference 32500, lot number 1008439200) complied with specifications.The batch record analysis shows that non-conformities were not detected during manufacturing and quality control processes.And review of previous complaints does not indicate any deviation on the product reference id 32 staph, reference 32500.Customer service recommended the customer verify the cleanliness of the automate or of the strip in use for a good recognition of the strips by the reader.If the absence of reagents cannot explain the non-recognition of the strips by the automate, it is imperative to add the revealing reagents in the strips following the package insert (08020) to obtain a correct identification of the strain tested.As the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.

• Brand Name: ID 32 STAPH 25STRIPS - 32500
• Type of Device: ID 32 STAPH 25STRIPS - 32500
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 12313669
• MDR Text Key: 266279127
• Report Number: 9615754-2021-00225
• Device Sequence Number: 1
• Product Code: JWX
• UDI-Device Identifier: 03573026066499
• UDI-Public: 03573026066499
• 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: 09/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 32500
• Device Lot Number: 1008439200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1