VIDAS® LYME IGG
Received Feb 2, 2016
Report 3002769706-2016-00030 · MDR key 5404862
Device
Product problems
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION INTO THE FALSE NEGATIVE EVENT WAS PERFORMED BY BIOMERIEUX. THE RETURNED PATIENT SAMPLES WERE ANALYZED ON 2 LOTS OF VIDAS® LYME IGG AS WELL. THE RESULTS OF THIS TESTING FOUND THE SAMPLE TO BE NEGATIVE FOR LYME IGG. FURTHER TESTING WAS PERFORMED ON LIA- LIAISON-DIASORIN (BORELIOSE SEROLOGY) AND ALL-DIAG LYME CHECK. THE RESULTS OF BOTH OF THOSE CONFIRMATORY TESTS WERE ALSO NEGATIVE FOR LYME IGG, CONFIRMING THE VIDAS® LYME IGG RESULT. ADDITIONALLY, THE BATCH PRODUCTION RECORD WAS REVIEWED. NO ANOMALIES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INVESTIGATION, THE PERFORMANCE OF VIDAS® LYME IGG TESTS ARE WITHIN SPECIFICATIONS AND CANNOT CONFIRM THE CUSTOMER'S RESULT.
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED TO BIOMERIEUX THAT THEY HAVE OBSERVED DISCREPANT RESULTS WHEN THE VIDAS LYME IGG TEST. ONE PATIENT WAS TESTED THREE TIMES. THE THREE SAMPLES WERE DETERMINED NEGATIVE ON VIDAS IGG. A CONFIRMATORY TEST BY WESTERN BLOT BIOADVANCE WAS POSITIVE FOR LYME IGG. THE PATIENT WAS PREVIOUSLY DIAGNOSED AS POSITIVE FOR ANKYLOSING SPONDYLITIS AND POLYARTHRALGIA. WHEN SPECIFICALLY REQUESTED, THE CUSTOMER INDICATED THERE WAS NO IMPACT TO PATIENT OR PATIENT TREATMENT.