API? RAPID ID 32 STREP 32600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-12-21 for API? RAPID ID 32 STREP 32600 manufactured by Biomerieux, Sa.

Event Text Entries

[96066917] A customer in (b)(6) notified biom? Rieux 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 biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2017-00476
MDR Report Key7138768
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-12-21
Date of Report2018-05-07
Date Mfgr Received2018-04-12
Device Manufacturer Date2017-05-31
Date Added to Maude2017-12-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX, SA
Manufacturer Street3 ROUTE DE PORT MICHAUD
Manufacturer CityLA BALME LES GROTTES ISERE, 38390
Manufacturer CountryFR
Manufacturer Postal Code38390
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPI? RAPID ID 32 STREP
Generic NameAPI? RAPID ID 32 STREP
Product CodeJTO
Date Received2017-12-21
Catalog Number32600
Lot Number1005704650
ID Number03573026066536
Device Expiration Date2018-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, SA
Manufacturer Address3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-21

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