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U.S. Department of Health and Human Services

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

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BIOMERIEUX, SA API® RAPID ID 32 STREP Back to Search Results
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.
 
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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 Key7138768
MDR Text Key96066917
Report Number1950204-2017-00476
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
C1 EXEMPT
Number of Events Reported1
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 Date05/31/2018
Device Catalogue Number32600
Device Lot Number1005704650
Other Device ID Number03573026066536
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 Received12/21/2017
Supplement Dates Manufacturer Received04/12/2018
Supplement Dates FDA Received05/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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