VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Nov 24, 2015 · Event occurred Jun 6, 2015
Report 1950204-2015-00105 · MDR key 5246760
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT DISCREPANT ORGANISM IDENTIFICATIONS IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE GN LOT TESTED WITH THE MISIDENTIFICATION: 241330040. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED. THE RESULTS ARE AS FOLLOWS: CUSTOMER RESULTS: THE LAB REPORT SHOWED SEVEN (7) ATYPICAL REACTIONS FOR S. MALTOPHILIA (4 ATYPICAL NEGATIVE; 3 ATYPICAL POSITIVE) ACCORDING TO THE GN KNOWLEDGE BASE (NEGATIVE = BGLU, LIP, PHOS, GGAA AND POSITIVE = DCEL, AGLTP, DGLU). NO INFORMATION WAS AVAILABLE REGARDING THE CUSTOMER'S SET UP PROCEDURE. INVESTIGATION CONCLUSION: AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE THE FOLLOWING: - CONTAMINATION - MIXED CULTURE - USE OF NON-RECOMMENDED MEDIA - USER SET UP ERRORS - AN ATYPICAL STRAIN. IN CONCLUSION, A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. INITIAL QC PERFORMANCE TESTING WAS REVIEWED FOR VITEK® 2 GRAM-NEGATIVE (GN) ID TEST KIT LOT 241330040. THE LOT PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING. WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. NO FURTHER ACTIONS DEEMED NECESSARY.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE ISOLATE WAS SENT TO A REFERENCE LABORATORY (FUNED) FOR CONFIRMATORY TESTING. INITIAL CUSTOMER ID: (B)(6). REPEAT TEST: STENOTROPHOMAS MALTOPHILIA. FUNED ID: STENOTROPHOMAS MALTOPHILIA. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.