MAUDE Adverse Event Report: BIOMÉRIEUX SA ID 32 C 25STRIPS+25MEDIA

Model Number	32200
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: id 32 c is a qualitative standardized system for the identification of yeasts.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.Issue description: a customer in (b)(6) reported to biomérieux potential delayed results in association with the product id 32 c 25strips+25media (ref 32200, batch number 1008781060, expiry date 11-jun-2022).The customer stated they observed five (5) strips with visual defect.It was reported that the customer claimed a delayed result; the customer could not use the product due to a visual defect observed before use, and that five strips were impacted in a kit of twenty five strips.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.An investigation will be initiated.
Additional Manufacturer Narrative
Context: a customer in china reported to biomérieux potential delayed results in association with the product id: 32 c 25strips+25media (ref 32200, batch number 1008781060, expiry date 11-jun-2022).Investigation: retained sample analysis: the retained sample strips for product reference 32200, lot number 1008781060 were verified.The investigation on the retained samples for this lot did not identify any defective strips in the final packaging.The 25 strips included in the kit are correctly printed.Manufacturing process and batch record analysis: during the investigation, the manufacturing process was analyzed and tests were performed in the manufacturing area to identify a potential root cause related to this issue.The batch record analysis did not identify non-conformities nor observations which could explain the issue observed by the customer.The manufacturing process and batch record analysis concluded that no root cause can be identified, and that the issue was isolated during the manufacturing of this lot number.Furthermore, a statistical control related to the strips printing is already implemented in the manufacturing process and the number of strips with the issue reported by the customer compared to the lot size is compliant with the specifications.Complaint trend analysis: on the (b)(6) 2022, a complaint trend analysis was performed on id 32 c, product reference 32200, lot number 1008781060 related to the current complaint.No other complaint was registered on this lot number for this issue.Conclusion: the investigation on the retained samples for the impacted lot 1008781060, product reference 32200, did not identify any defective strips in the final packaging.The manufacturing process and batch record analysis conclude that no root cause can be identified and that the issue is an isolated issue that occurred during the manufacturing of this lot number.A statistical control related to the strips printing is already implemented in the manufacturing process.Complaint trend analysis does not show any deviation for the product reference id: 32 c (reference 32200, lot number 1008781060).This issue therefore appears to be an isolated issue.As the investigation did not identify any root cause and as the issue is isolated, neither corrective nor preventive actions will be implemented.

• Brand Name: ID 32 C 25STRIPS+25MEDIA
• Common Device Name: ID 32 C 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: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 13497487
• Report Number: 9615754-2022-00021
• Device Sequence Number: 3895421
• Product Code: JXB
• UDI-Device Identifier: 03573026066383
• UDI-Public: 03573026066383
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 06/11/2022
• Device Model Number: 32200
• Device Catalogue Number: 32200
• Device Lot Number: 1008781060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown