MAUDE Adverse Event Report: BIOMÉRIEUX SA RAPID ID 32 STREP 25STRIPS - 32600

Catalog Number 32600

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

Intended use: rapid id 32 strep is a qualitative standardized system for the identification of streptococci and enterococci, and those most common related organisms, in four hours.It uses miniaturized tests as well as a specifically 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 japan notified biomérieux that they observed "strange positive reactions" while testing a patient streptococcus dysgalactiae ssp.Equisimilis strain with the rapid id 32 strep (ref 32600, lot 1009964540).The customer reported that they tested the s.Dysgalactiae ssp.Equisimilis strain randomly nine (9) times, and during three (3) of the tests the entire top row of the test kit turned red.The customer provided results from seven (7) tests including 4 unacceptable profiles and 3 good profiles.There is no evidence of a misidentification.There is no indication or report from the customer that this event led to or contributed to death, serious injury, or serious deterioration in the state of health of the patient.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint that the customer observed "strange positive reactions" while testing a patient streptococcus dysgalactiae ssp.Equisimilis strain with the rapid id 32 strep (ref 32600, lot 1009964540).---investigation--- complaint trend analysis: on 04apr2024, a complaint trend analysis was performed since 2020 on the product reference 32600.The complaint trend analysis does not show any negative trend for the product rapid id 32 strep, reference 32600.Retained samples analysis: biomérieux retains samples of every lot number released to the market.The retained samples from the impacted lot number 1009964540 were tested in parallel with an internal lot number used as a reference lot (reference 32600, lot 1009887700, expiry date 15 feb 2024).The tests were performed by using the quality control (qc) strains streptococcus equi ssp equi atcc 33398, streptococcus agalactiae atcc 12401 and streptococcus vestibularis atcc 49124 mentioned in the package insert 07924 k.Compliant results were obtained for the three strains tested on the two rapid id 32 strep lot numbers tested.Strain return analysis: the customer provided the strain for investigational testing.The strain was tested on the impacted lot number 1009964540 and on a reference lot of the product reference 32600.The identification results obtained were a very good identification to streptococcus dysgalactiae ssp equisimilis on both lots.The analysis of the biochemical profile obtained during the investigation (11132041110) compared to the profile you obtained allowed to highlight a difference of results particularly for the seven following tests : man, sor, raf, mel, mlz, darl and bman.Negative results were obtained during the investigation while the customer obtained positive results.These seven tests are expected to be negative (0%) as indicated in the database of the product reference 32600 for streptococcus dysgalactiae ssp equisimilis strains.Conclusion: no product issue was observed on the lot number 1009964540 during the tests performed on the retained samples with the three qc strains tested.The results that the customer obtained were not reproduced during the investigation with the impacted strain: a very good identification to streptococcus dysgalactiae ssp equisimilis was obtained on the complained lot number 1009964540 and on the reference lot.The complaint trend analysis does not show any negative trend for the product rapid id 32 strep, reference 32600.

• Brand Name: RAPID ID 32 STREP 25STRIPS - 32600
• Type of Device: RAPID ID 32 STREP 25STRIPS - 32600
• 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 18111107
• MDR Text Key: 327893712
• Report Number: 9615754-2023-00051
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026066536
• UDI-Public: 03573026066536
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 32600
• Device Lot Number: 1009964540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1