VIDAS® LYME IGM II
Received Sep 28, 2016
Report 3002769706-2016-00348 · MDR key 5984256
Device
Product problems
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- Insufficient Information
- No Consequences Or Impact To Patient
- Insufficient Information
Narrative
Description of Event or Problem
A CUSTOMER REPORTED TO BIOMERIEUX A DISCREPANT RESULT EVENT OCCURRED WHEN USING THE VIDAS LYME IGM TEST KIT. THE CUSTOMER REPORTED THAT THE VIDAS LYME IGM RETURNED A NEGATIVE RESULT; HOWEVER, CONFIRMATORY TESTING BY WESTERN BLOT RETURNED A POSITIVE RESULT. WHEN SPECIFICALLY ASKED, THE CUSTOMER INDICATED NO ADVERSE IMPACT TO THE PATIENT OR DELAY IN RESULTS WAS EXPERIENCED AS A RESULT OF THIS EVENT. AN INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO INVESTIGATE THIS EVENT.
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO A CUSTOMER IN THE UNITED STATES REPORTING A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE VIDAS® LYME IGM II ASSAY. THE RESULT WAS POSITIVE WHEN TESTED VIA ALTERNATE METHOD (WESTERN BLOT). BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. EVALUATION OF THE BATCH RECORDS FOR VIDAS® LYME IGM II LOT 1004589020 INDICATED THE ASSAY IS WITHIN THE EXPECTED PERFORMANCE OF THE KIT. FOLLOW-UP DISCUSSION WITH THE CUSTOMER INDICATED THE PATIENT SAMPLES WERE BEING TESTED FOR CORRELATION STUDIES BEFORE THE LABORATORY WENT LIVE WITH VIDAS® LYME IGG AND LYME IGM. THE CORRESPONDING RESULTS WERE NOT REPORTED TO A PHYSICIAN OR USED FOR TREATMENT DECISIONS FOR ANY PATIENT. IN ADDITION, THE CUSTOMER STATED THEY WERE PREVIOUSLY MISTAKEN; THE VIDAS® LYME IGM II ASSAY RESULTS WERE ACTUALLY IN AGREEMENT WITH THE WESTERN BLOT RESULTS. THEREFORE, THERE IS NO MALFUNCTION ASSOCIATED WITH THIS REPORT.
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO A CUSTOMER IN THE UNITED STATES REPORTING A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE VIDAS LYME IGM II ASSAY. THE RESULT WAS POSITIVE WHEN TESTED VIA ALTERNATE METHOD (WESTERN BLOT). BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. EVALUATION OF THE BATCH RECORDS FOR VIDAS LYME IGM II LOT 1004589020 INDICATED THE ASSAY IS WITHIN THE EXPECTED PERFORMANCE OF THE KIT. FOLLOW-UP DISCUSSION WITH THE CUSTOMER INDICATED THE PATIENT SAMPLES WERE BEING TESTED FOR CORRELATION STUDIES BEFORE THE LABORATORY WENT LIVE WITH VIDAS LYME IGG AND LYME IGM. THE CORRESPONDING RESULTS WERE NOT REPORTED TO A PHYSICIAN OR USED FOR TREATMENT DECISIONS FOR ANY PATIENT. IN ADDITION, THE CUSTOMER STATED THEY WERE PREVIOUSLY MISTAKEN; THE VIDAS LYME IGM II ASSAY RESULTS WERE ACTUALLY IN AGREEMENT WITH THE WESTERN BLOT RESULTS. THEREFORE, THERE IS NO MALFUNCTION ASSOCIATED WITH THIS REPORT.