VIDAS® LYME IGG
Received Mar 15, 2016
Report 3002769706-2016-00055 · MDR key 5501162
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
A CUSTOMER IN (B)(6) REPORTED A FALSE NEGATIVE RESULT WHILE USING PRODUCT; VIDAS LYME IGG TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: NO ADDITIONAL COMPLAINTS FOR VIDAS LYME IGG TEST KIT LOT 1004350980/160914-0 SINCE JANUARY 2015. ANALYSIS OF BATCH HISTORY RECORDS INDICATES THERE WAS NO ANOMALY DETECTED DURING THE CONTROL PROCESS. TESTED ONE (1) NEGATIVE SAMPLE AND THREE (3) POSITIVE SAMPLES ON THE RETAINED VIDAS LYME IGG TEST KIT LOT 1004350980. RESULTS- RESULTS OBTAINED FOR THE FOUR (4) SAMPLES, WERE WITHIN SPECIFICATIONS. ANALYSIS OF THE CONTROL CARD FOR THESE FOUR (4) SAMPLES SHOW THAT VIDAS LYME IGG LOT 1004350980 IS IN TREND WITH OTHER LOTS. WESTERN BLOT TEST IGG RESULT- THERE WERE ONLY THREE (3) POSITIVE BANDS WITH TWO (2) REPRESENTING EARLY MARKERS (P41 AND OSPC). ON THE WESTERN BLOT TEST IGM, THERE WERE FIVE (5) POSITIVE BANDS WITH FOUR (4) REPRESENTING EARLY MARKERS (OSPC). VIDAS- NEGATIVE CONTROL RESULT (C2 ) WAS 0.00 VT WHILE THE SAMPLE RESULT WAS 0.10 VT WITH A LOW DETECTION, WHICH MAY REPRESENT AN EARLY INFECTION WITH IGG PRESENT BUT AT A RATE TOO LOW TO BE DETECTED POSITIVE; HOWEVER, AT A SUFFICIENTLY HIGH RATE TO BE DETECTED BY WESTERN BLOT, WHICH IS A MORE SENSITIVE METHOD. PER THE VIDAS LYME IGG PACKAGE INSERT, ANTIBODY DETECTION METHODS DO NOT PROVIDE DEFINITIVE RESULTS FOR ESTABLISHING OR RULING OUT A DIAGNOSIS OF LYME BORRELIOSIS. A NEGATIVE RESULT IN THE VIDAS LYME IGM AND VIDAS LYME IGG ASSAYS DOES NOT RULE OUT THE POSSIBILITY OF B. BURGDORFERI INFECTION IN A PATIENT. PATIENTS IN EARLY STAGES OF INFECTION OR WHO HAVE UNDERGONE ANTIBIOTIC THERAPY, MAY NOT PRODUCE MEASURABLE IGM AND IGG. PATIENTS WITH CLINICAL HISTORY AND/OR SYMPTOMS SUGGESTIVE OF LYME DISEASE, BUT WITH NEGATIVE TEST RESULTS, SHOULD BE REPORTED AS "NO DETECTABLE ANTIBODIES TO B. BURGDORFERI." A SECOND SPECIMEN SHOULD BE COLLECTED IN 4-6 WEEKS. IT IS ESTIMATED THAT IN 50% OF SUBJECTS, IN THE PRIMARY STAGE OF DISEASE, ANTIBODY LEVELS IN BLOOD REMAIN BELOW THE DETECTABLE THRESHOLD. CONCLUSION- VIDAS LYME IGG TEST KIT IS PERFORMING WITHIN ACCEPTABLE LIMITATIONS AS NOTED IN THE PACKAGE INSERT.
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED A FALSE NEGATIVE RESULT WHILE USING PRODUCT; VIDAS LYME IGG TEST KIT. THERE WERE NO REPORTS OF PATIENT HARM.