MAUDE Adverse Event Report: BIOMERIEUX SA API® RAPID ID 32 STREP

Catalog Number 32600

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomérieux to report the occurrence of misidentification of enterococcus faecium as enterococcus gallinarum in association with the api® rapid id 32 strep test.The customer stated that testing via api® 20 strep, vitek® ms and vitek® 2 obtained the expected result of enterococcus faecium.There was no indication or report from the laboratory that the discrepant results led to any adverse event related to a patient's state of health.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in austria reported a misidentification of enterococcus faecium as enterococcus gallinarum in association with the api® rapid id 32 strep test.(lot 1005991890).The customer submitted one strain for evaluation.An internal biomérieux investigation was performed.The conformity of lot 1005991890 was confirmed with all qc strains tested for the release of this reference (streptococcus agalactiae atcc 12401, streptococcus equi ssp equi atcc 33398 and streptococcus vestibularis atcc 4124).The customer strain was tested on two (2) retained lots, the customer lot 1005991890 and a reference lot 1005704660.The results included: acceptable identification of enterococcus faecium with the customer lot.Doubtful profile of enterococcus gallinarum on the reference lot.Therefore, the customer's identification was not reproduced.The 16s analysis resulted in the identification of enterococcus faecium (on the basis of the blast result).In conclusion, the identification of the customer's submitted strain was confirmed to enterococcus faecium by 16s and testing of the customer lot of the api®rapid id 32 strep test.The customer's result was not reproduced.

• Brand Name: API® RAPID ID 32 STREP
• Type of Device: API® RAPID ID 32 STREP
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383, france ; FR
• MDR Report Key: 7447656
• MDR Text Key: 106271487
• Report Number: 3002769706-2018-00055
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026066536
• UDI-Public: 03573026066536
• Combination Product (y/n): N
• PMA/PMN Number: CL. I 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2018
• Device Catalogue Number: 32600
• Device Lot Number: 1005991890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1