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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of misidentifications for blood culture isolates from two patients in association with api® rapid id 32 strep (lot 1005704650) test strip.The customer reported the api® test was performed from columbia blood agar, and an identification of enterococcus gallinarum was obtained twice with the api® test strip.Testing was also performed with vitek® 2 and vitek® ms, and both identified enterococcus faecium (99.9%).The customer stated an identification of enterococcus faecium was reported to the physician.The customer reported there was no impact to patient results or treatment, and there was no delay for reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported misidentifications of enterococcus faecium as enterococcus gallinarum for two patient isolates in association with api® rapid id 32 strep (lot 1005704650) test strip.The customer submitted the strains and test strips for evaluation.An investigation was performed.Rapid id 32 strep strips from the retained kit of the impacted batch 1005704650 were tested with each strain mentioned in the current package insert version 07924i - fr - 2009/03 : ° streptococcus agalactiae atcc 12401 (cq 182) ° streptococcus equi spp equi atcc 33398 (cq 176) ° streptococcus vestibularis atcc 49124 (cq 178) excellent identification results were obtained for all three of the strains.The customer's strain was tested on the following rapid id 32 strep strips : ° retention kit batch 1005704650 ° customer batch 1005704650 ° reference batch all three batches gave an identification to enterococcus gallinarum with a doubtful profile.A doubtful profile requires the customer to perform complementary tests for identification.The internal sequencing test was not successful for identification of the customer's strain.The investigation did not reproduce the customer's issue.In conclusion, the customer's strain has similar biochemical behaviors with an enterococcus faecium strain.A doubtful profile was obtained with the customer's strain, indicating additional testing is needed for identification.The manufacturer's fda registration number of 1950204 located within the report number of 1950204-2017-00476, should have been reported as 3002769706 to reflect the device manufacturing site.

• 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, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7138768
• MDR Text Key: 96066917
• Report Number: 1950204-2017-00476
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

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: 05/31/2018
• Device Catalogue Number: 32600
• Device Lot Number: 1005704650
• Other Device ID Number: 03573026066536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1