VIDAS® LYME IGG II 60 TESTS
Received Apr 3, 2020
Report 8020790-2020-00039 · MDR key 9920397
Device
Generic name
Vidas® Lyme Igg Ii 60 Tests
Manufacturer
Biomerieux SaModel number
417401Catalog number
417401
Lot number
1007649070
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- 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 WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF FALSE NEGATIVE RESULTS FOR THREE PATIENTS WHEN USING VIDAS® LYME IGG II 60 TESTS (REF. 417401, LOT 1007649070). NO SAMPLES WERE SUBMITTED BY THE CUSTOMER FOR THE INVESTIGATION. A COMPLAINT REVIEW DID NOT IDENTIFY ANY OTHER OCCURRENCES OF FALSE NEGATIVE RESULTS OBTAINED FOR THIS LOT NUMBER. REVIEW OF PRODUCTION RECORDS REVEALED NO ANOMALIES DURING MANUFACTURING, CONTROL, AND PACKAGING PROCESSES FOR THIS LOT. THE COMPLAINT LABORATORY TESTED 8 INTERNAL SAMPLES WITH 6 DIFFERENT LOTS INCLUDING THE LOT USED BY THE CUSTOMER. ANALYSIS OF CONTROL CHARTS SHOW THAT ALL RESULTS ARE WITHIN SPECIFICATIONS AND THE CUSTOMER'S LOT IS IN TREND OF THE OTHER LOTS EVALUATED. ADDITIONALLY, 4 INTERNAL SAMPLES WERE TESTED WITH A RETAIN SAMPLE OF THE CUSTOMER'S LOT AND ALL RESULTS WERE WITHIN EXPECTED SPECIFICATIONS. THERE WAS NO DRIFT OBSERVED. WITHOUT THE CUSTOMER'S SAMPLES, FURTHER INVESTIGATION CANNOT BE COMPLETED AND THE ROOT CAUSE FOR THE CUSTOMER'S ISSUE CANNOT BE DETERMINED. ACCORDING TO THE INVESTIGATIONAL TESTING PERFORMED, VIDAS LYME IGG II REF 417401 LOT 1007649070 / 201226-0 IS WITHIN EXPECTED PERFORMANCE. SEE H10 FOR ADDTL MFG NARRATIVE.
Description of Event or Problem
A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS FOR THREE PATIENTS WHEN USING VIDAS® LYME IGG II 60 TESTS (REF. 417401, LOT 1007649070). FOR THREE PATIENTS, THE CUSTOMER OBTAINED NEGATIVE RESULTS WHEN USING VIDAS LYME IGG II 60 TESTS, LOT 1007649070 WITH RESULTS RESPECTIVELY AT 0.02, 0.03 AND 0.04. THE SAME SAMPLES TESTED WITH WESTERN BLOT IGG ASSAY SHOWED POSITIVE RESULTS. SAMPLE (B)(6), RFV:28.,TV: 0.02, RESULT:NEGATIVE. SAMPLE (B)(6), RFV:30, TV:0.03, RESULT: NEGATIVE. SAMPLE (B)(6): RFV , TV:0.04, RESULT NEGATVIE. WESTERN BLOT IGG SAMPLE (B)(6) POSITIVE. SAMPLE (B)(6) POSITIVE. SAMPLE (B)(6) POSITIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE NEGATIVE RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.