BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 8409560 · Received March 11, 2019

    Report

    Report Number
    8020790-2019-00017
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSE NEGATIVE RESULTS WITH A QUALITY CONTROL VIROTROL SAMPLE IN ASSOCIATION WITH THE VIDAS® CMV IGM ASSAY (LOT 1006946280). THE CUSTOMER DID NOT SUBMIT ANY SAMPLES FOR EVALUATION. **COMPLAINT TRENDING ANALYSIS** ELEVEN COMPLAINTS WERE RECEIVED FOR AN EXTERNAL CONTROL PROBLEMS WITH DIFFERENT PROGRAMS AND ON DIFFERENT CMVM BATCHES, AND THERE WAS NO INDICATION OF A TREND TO THE CUSTOMER'S ISSUE. ** CONTROL CHARTS ANALYSIS** FOUR INTERNAL SERA WERE TESTED ON SIX DIFFERENT BATCHES OF VIDAS CMVM INCLUDING THE LOTS CONCERNED BY THIS COMPLAINT. ALL THE RESULTS WERE WITHIN SPECIFICATIONS AND VIDAS CMV IGM REFERENCE 30205 LOT 1006946280/191004-0, AND LOT 1007040660/191112-0 ARE IN THE TREND OF THE OTHER LOTS. **TESTS PERFORMED BY COMPLAINTS LABORATORY ** THE CUSTOMER LOT 1006946280/191004-0, AND THREE OTHER LOTS 1007040660/191112-0; 1006712530/190611-0; 1006841900/190824-0; WERE TESTED USING THREE INTERNAL SAMPLES (BLOOD DONORS). ALL SAMPLES WERE WITHIN EXPECTED RANGES WITH RESULTS CLOSE TO THOSE OBTAINED BEFORE BATCH RELEASE. THE FINAL INTERPRETATION FOR EACH SAMPLE WAS AS EXPECTED (POSITIVE) ON ALL BATCHES. INTERNAL SAMPLE CTCB (FRENCH EXTERNAL QUALITY ASSESSMENT ) 1825 WAS ALSO POSITIVE ON ALL THREE LOTS AND CONFORMED TO EXPECTATIONS. INTERNAL VIROTROL SAMPLES (128660 AND 128670) TESTED WERE TESTED ON ALL LOTS AND RESULTS WERE WITHIN CUSTOMER ACCEPTABLE VALUES FOR ONE LOT. FOR THE OTHER THREE LOTS THE VALUES OBTAINED ARE LOWER THAN THE TARGET VALUES SET BY THE CUSTOMER. VIDAS CMVM, LOT 190611-0 : LOT 128660: 1.43 VT AND LOT 128670: 1.30 VT ACCEPTABLE VALUES VIDAS CMVM 191112-0 , LOT 128660 1.07 VT AND LOT 128670 1.02 VT) POSITIVE RESULTS. VIDAS CMVM 190824-0 , LOT 128660 0,95 VT POSITIVE AND LOT 128670 0,87 VT: EQUIVOCAL RESULT (WITHOUT INTERPRETATION CHANGE) FOR VIROTROL LOT 128670 VIDAS CMVM 191004-0 , LOT 128660 0.75 VT EQUIVOCAL AND LOT 128670 0.86 VT: EQUIVOCAL RESULT (WITHOUT INTERPRETATION CHANGE)ON BOTH BATCHES OF VIROTROL CONCLUSION: THE CUSTOMER'S LOW RESULTS WERE REPRODUCED ON VIROTROL SAMPLES. EQUIVOCAL RESULTS WERE OBSERVED INSTEAD OF POSITIVE RESULTS (BUT WITHOUT INTERPRETATION CHANGE DEPENDING ON THE BATCH OF VIDAS CMVM TESTED. THE ANOMALY WAS NOT REPRODUCED AND DID NOT OBSERVE ANY INTERPRETATION CHANGE ON THE SAMPLES FROM EFS (BLOOD DONORS), NOR ON ANOTHER QUALITY CONTROL MATERIAL (CTCB PROGRAM) PRESENTING VALUES CLOSE TO VIROTROL RESULTS. IT IS RECOMMENDED THAT EACH LABORATORY ESTABLISHES ITS OWN RANGE FOR EACH ANALYTE, AS STATED IN THE PACKAGE INSERT VIROTROL TORCH-M (**). QUALITY CONTROL SAMPLES (SUCH AS VIROTROL TORCH M) ARE NOT IDENTICAL TO PATIENT SAMPLES. THE QUALITY CONTROL MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX AND CONTROL RESULTS. AS NOTED IN THE CLSI GUIDELINE EP14-A3, "CURRENT SCIENTIFIC DATA SUGGEST THAT SUCH USE OF PT/EQA RESULTS IS NOT ALWAYS FEASIBLE BECAUSE OF MATRIX EFFECTS. THESE PROCESSED MATERIALS US AS PT/EQA SAMPLES SOMETIMES DO NOT BEHAVE LIKE PATIENT SAMPLES ROUTINELY ANALYZED IN THE LABORATORY. BIASES NOT GENERALLY SEEN WITH FRESH BIOLOGICAL FLUIDS, ARE FREQUENTLY SEEN WITH PT/EQA SAMPLES". ACCORDING TO THE ALL ABOVE DATA, VIDAS CMV IGM REFERENCE 30205 BATCH 1006946280/191004-0, AND BATCH 1007040660/191112-0 ARE WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED (B)(6) RESULTS IN ASSOCIATION WITH THE VIDAS® CMV IGM ASSAY (LOT 1006946280). THE CUSTOMER REPORTED THAT THEY RAN A VIROTROL SAMPLE WITH LOT 1006946280, AND RESULTS WERE BETWEEN (B)(6), WITH AN INTERPRETATION OF (B)(6) TO EQUIVOCAL. THE CUSTOMER STATED THE PREVIOUS LOT OBTAINED BETWEEN (B)(6), WITH A (B)(6)INTERPRETATION. NO OTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201032 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 1006946280

    Patients

    Seq Age Sex Outcome Treatment
    1