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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD

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BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A customer in (b)(6) reported the vitek 2 gram-negative (gn) id test kit misidentified a vibrio cholera organism as aeromonas species. Biomerieux has requested submittal of patient isolate for internal testing. There is no indication or report from the hospital or treating physician to biomerieux that the organism misidentification led to any adverse event related to the patient's state of health. An internal biomerieux investigation will be initiated.
 
Manufacturer Narrative
Biomérieux internal investigation was conducted. Seven gram negative rods and associated lab reports were submitted by the customer for vitek® 2 evaluation. For each organism, a swab and a slant were submitted and both were subcultured to trypticase soy agar with 5% sheep blood (tsab) and macconkey agar. Of the seven isolates, six were non-viable after 48 hours of incubation. The viable organism was submitted because the gn id card identified it as aeromonas hydrophila/caviae, but the customer said it was a vibrio cholera and confirmed it by serotyping. Testing of the organism included one gn id card from same lot that was tested by the customer, one card from a random lot and 16s sequencing. The two gn id cards gave excellent identification calls of aeromonas hydrophila/caviae and the 16s sequencing results of aeromonas hydrophila/caviae confirm the gn id results to be correct. The laboratory reports for the non-viable organisms and for others sent due to misidentifications by the gn id card were reviewed against the reactions for the expected identifications. Without viable organisms for testing or archived data, it is not possible to determine what may have caused the misidentifications. Evaluation of the manufacturing qc batch record for gn id lot # 241353110 indicated the lot passed qc performance testing. Review of complaint records indicated this is the only complaint of record for the reported issue. The investigation concluded that the vitek® 2 gn id card is performing as intended.
 
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Brand NameVITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 GN ID CARD
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer Contact
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5381123
MDR Text Key36481090
Report Number1950204-2016-00009
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
PMA/PMN Number
CL. I EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/30/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2016
Device Catalogue Number21341
Device Lot Number241353110
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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