VITEK® 2 GN TEST KIT
Received Aug 5, 2016
Report 1950204-2016-00086 · MDR key 5851698
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED DUE TO VITEK® 2 GN ID MISIDENTIFICATION OF SALMONELLA SER PARATYPHI A AS SHIGELLA GROUP. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. INVESTIGATION DETAILS: THE ISOLATE WAS SUBCULTURED AND TESTING INCLUDED TWO (2) VITEK 2 GN ID CARDS FROM THE SAME LOT TESTED BY THE CUSTOMER, TWO (2) CARDS FROM A RANDOM LOT AND API 20E. THE FOUR VITEK 2 GN ID CARDS GAVE EXCELLENT IDENTIFICATION CALLS OF ESCHERICHIA COLI. THE API 20E PROVIDED IDENTIFICATION TO SALMONELLA SER PARATYPHI A WITH A 99.5% CONFIDENCE LEVEL. IT SHOULD BE NOTED THAT, WHEN AN IDENTIFICATION OF SHIGELLA / SALMONELLA IS MADE BY VITEK 2 GN ID CARDS, AN ANALYSIS MESSAGE OF "CONFIRM BY SEROLOGICAL TESTS" IS GIVEN ON THE LAB REPORT. THE INVESTIGATION CONCLUDED THIS IS AN ATYPICAL STRAIN FOR THE VITEK 2 GN KNOWLEDGE BASE.
Additional Manufacturer Narrative
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Description of Event or Problem
A CUSTOMER IN UNITED STATES NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK 2 GN TEST KIT (B)(4) INVOLVING A BLOOD CULTURE. THE CUSTOMER REPORTED USING THE VITEK 2 GN TEST KIT THAT IDENTIFIED THE ORGANISM AS ONE OF THE SHIGELLA GROUP. HOWEVER, SEROLOGY WAS POSITIVE FOR SALMONELLA POLYVALENT ANTISERA. THE CUSTOMER INDICATED THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OR ADVERSE EVENTS.