MalfunctionLSR
VIDAS® LYME IGG
Received Dec 20, 2016
Report 3002769706-2016-00519 · MDR key 6190529
Device
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER FROM (B)(6), REPORTED TO BIOMÉRIEUX A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE VIDAS® LYME IGG TEST. A PATIENT SAMPLE WAS COLLECTED AND TESTED WITH VIDAS® LYME IGG AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS THEN TESTED USING THE WESTERN BLOT TECHNIQUE AND THE RESULT WAS POSITIVE FOR LYME IGG. THE LYME IGM TEST WAS NOT PERFORMED. BOTH RESULTS WERE GIVEN TO THE PATIENT. THE IMPACT OF RESULTS TO THE PATIENT IS NOT KNOWN. THE CUSTOMER SUBMITTED THE TEST REPORTS TO BIOMERIEUX FOR REVIEW, HOWEVER THE ISOLATE IS NOT AVAILABLE FOR EVALUATION.