VIDAS® MUMPS IGG ASSAY
Received Jan 13, 2016
Report 3002769706-2016-00008 · MDR key 5365077
Device
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
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. HOWEVER, THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX REQUEST FOR SAMPLE SUBMITTAL AND THE REFERENCED PRODUCT LOT WAS ALREADY EXPIRED. ANALYSIS OF THE MANUFACTURING QC BATCH RECORD FOR THE REFERENCED LOT INDICATED NO ABNORMALITY. AS INDICATED IN THE INSTRUCTIONS FOR USE, VIDAS MUMPS IGG PERFORMANCE DOES NOT CLAIM 100% IN TERM OF SPECIFICITY OR SENSITIVITY. VIDAS MUMPS IGG AND ARUP USE DIFFERENT TESTING METHODS; THEY ARE QUALITATIVE ELFA TEST AND SEMI-QUANTITATIVE CHEMILUMINESCENT TEST, RESPECTIVELY. WITHOUT THE ARUP PERFORMANCE SPECIFICATIONS (SENSITIVITY AND SPECIFICITY) AND THE LACK OF THIRD CONFIRMATORY METHOD, IT IS NOT POSSIBLE TO DETERMINE WHICH RESULT IS CORRECT. THE INVESTIGATION CONCLUDED THAT NO PRODUCT PERFORMANCE ISSUE WAS CONFIRMED FOR THE REFERENCED LOT OF VIDAS MUMPS IGG ASSAY.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANCY IN RESULTS WITH THE VIDAS MUMPS IGG TEST. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMERIEUX THAT THE ASSOCIATED RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. SUBMITTAL OF THE PATIENT SAMPLE HAS BEEN REQUESTED. BIOMERIEUX INVESTIGATION WILL BE INITIATED.