VIDAS LH
Received Jun 5, 2015 · Event occurred Sep 5, 2014
Report 3002769706-2015-00040 · MDR key 4821543
Device
Product problems
- Device Expiration Issue
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
ON (B)(6) 2015 A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT OUT OF RANGE VALUES FOR THE VIDAS LH TEST (REF. 30406 LOT 1002870450) OBTAINED WITH THE (B)(6) CNQS (NATIONAL QUALITY CONTROL) IA72 AND IA73. THE CNQ WAS ISSUED TO THE CUSTOMER IN SEPTEMBER 2014 AND THE RESULTS WERE ANALYZED BY (B)(6) IN JANUARY 2015. THE REASON FOR DELAY IN REPORTING TO THE MANUFACTURER IS UNKNOWN. THE LOT NUMBER USED BY THE CUSTOMER HAS EXPIRED. NO FURTHER ANALYSES CAN BE PERFORMED FOR THIS LOT. THE RANGES DEFINED BY THE COMPETENT AUTHORITY (B)(6) FOR THIS TEST ARE: IA72 RANGES: 14% (2.28-3.02) MIU\ML. THE CUSTOMER OBTAINED: 3.1 MUI/ML. PEER-TO-PEER AVERAGE: 2.65 MUI/ML. IA73 RANGES: 12% (19.38-24.66) MIU\ML. THE CUSTOMER OBTAINED: 24.7 MUI/ML. PEER-TO-PEER AVERAGE: 24.7 MUI/ML. THE CUSTOMER DID NOT PERFORM OTHER QC SAMPLES FOR THIS TEST. VIDAS LH IS AN AUTOMATED QUANTITATIVE TEST FOR USE ON THE VIDAS FAMILY INSTRUMENTS FOR THE DETERMINATION OF HUMAN LUTEINIZING HORMONE IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN), USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). THERE WAS NO DEATH, SERIOUS INJURY OR ADVERSE EVENT REPORTED AS A RESULT OF THE DISCREPANT RESULT.
Additional Manufacturer Narrative
INTERNAL INVESTIGATION, THOUGH LIMITED DUE TO EXPIRATION OF THE REFERENCED PRODUCT LOT, WAS PERFORMED BY BIOMÉRIEUX. EVALUATION OF COMPLAINT RECORDS INDICATE NO OTHER COMPLAINTS FOR THE REFERENCED LOT FOR THE SAME ISSUE. REVIEW OF BATCH RECORDS INDICATE NO NON-CONFORMITY ASSOCIATED WITH THE REFERENCED LOT. AS THE IMPACTED LOT EXPIRED 11FEB2015, NO RELEVANT DEVICE TESTING CAN BE PERFORMED.