BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 7782870 · Received August 14, 2018

    Report

    Report Number
    3002769706-2018-00147
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Report Date
    October 3, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER FROM VIETNAM WHO REPORTED FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® CMV (CYTOMEGALOVIRUS) IGM (LOT 1006247630). CUSTOMER'S RESULTS: 2ND AND 3RD SAMPLES OF THE SAME PATIENT TESTED WITH VIDAS : NEGATIVE (0.34 VT). 1ST, 2ND AND 3RD SAMPLES TESTED WITH COMPETITOR TESTS FOUND POSITIVES. NO RETURN SAMPLE WAS AVAILABLE FROM CUSTOMER SITE. COMPLAINT ANALYSIS ON LOT 1006247630/181207-0 DID NOT IDENTIFY ANY SIMILAR COMPLAINT FOR A SENSITIVITY ISSUE ON THIS BATCH. BATCH HISTORY RECORD WAS REVIEWED AND THERE WERE NO ISSUES DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES OF VIDAS CMV IGM LOT 1006247630. THE CONTROL CHARTS WERE REVIEWED FOR FIVE INTERNAL SAMPLES ON TWELVE LOTS INCLUDING THE CUSTOMER'S LOT 181207-0. ALL THE RESULTS WERE WITHIN THE SPECIFICATIONS. RESULTS FROM TESTING FIVE INTERNAL SAMPLES: CM 15 : 0.31VT TARGET : 0.31 VT RANGE :0.17-0.45 VT; CM 20 : 0.96 VT TARGET : 0.97 VT RANGE : 0.67-1.27 VT; CM 23 :0.55 VT TARGET : 0.55 VT RANGE : 0.35-0.75 VT; CM 26 :1.43 VT TARGET : 1.27 VT RANGE : 0.9-1.64 VT; CM 35 :1.14 VT TARGET : 0.97 VT RANGE : 0.67-1.27 VT. ALL THE RESULTS FOUND ARE WITHIN EXPECTED SPECIFICATION. CONCLUSION : THE RESULTS OBTAINED ON THE FIVE INTERNAL SAMPLES WERE CONFORMED TO THEIR RANGES AND SEROLOGICAL STATUS. ALL RESULTS ARE SIMILAR TO THOSE OBTAINED DURING THE BATCH RELEASE OF THE VIDAS CMVM LOT 1006247630. THE CONTROL CHART SHOWS THAT THE KIT VIDAS CMVM LOT 181207-0 IS IN THE TREND OF THE OTHER LOTS. AS MENTIONED IN THE PACKAGE INSERT VIDAS CMVM, (REF 30204), CHAPTER "PERFORMANCE": "SENSITIVITY: 90.24% 95% CONFIDENCE INTERVAL: 76.87 - 97.28%." IN THE ABSENCE OF PATIENT SAMPLES RETURN, NOR OTHER IMMUNOGLOBULIN RESULTS (CMV IGG ESPECIALLY), IT IS NOT POSSIBLE TO FURTHER INVESTIGATE AND CONCLUDE ABOUT THIS ISSUE, WHICH MAY BE LINKED TO A SPECIFIC BEHAVIOR OF THIS PATIENT SAMPLE. THE VIDAS CMVM LOT 1006247630/181207-0 IS STILL WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® CMV (CYTOMEGALOVIRUS) IGM (LOT 1006247630). THE CUSTOMER REPORTED THEY TESTED THREE SAMPLES FROM ONE PATIENT WITH (B)(6), AND RECEIVED (B)(6) RESULTS WITH THE VIDAS CMV IGM ASSAY WHILE OTHER METHODS (COBASS 6000, ELISA DIAPRO, PCR) WERE POSITIVE. SAMPLE 1 WAS TESTED WITH CMV IGM ON ELISA AND A POSITIVE RESULT WAS SENT TO PHYSICIAN, AND THE PCR RESULT WAS POSITIVE. SAMPLE 2 WAS TESTED WITH CMV IGM ON VIDAS AND A NEGATIVE RESULT WAS SENT TO PHYSICIAN, AND THE PCR RESULT WAS POSITIVE. SAMPLE 3 WAS TESTED AGAIN ON ELISA, VIDAS AND ANOTHER AUTOMATED IMMUNOLOGY SYSTEM. RESULTS WERE POSITIVE WITH ELISA AND THE IMMUNOLOGY SYSTEM, AND NEGATIVE WITH VIDAS. THE CUSTOMER STATED A WRONG RESULT WAS REPORTED TO A PHYSICIAN, BUT THE PATIENT WAS NOT HARMED OR TREATED INCORRECTLY, AS THE PHYSICIAN NOTICED THE DIFFERENT TEST RESULTS IMMEDIATELY. THE CUSTOMER STATED THERE WAS A DELAY IN REPORTING RESULTS WHICH TOOK TWICE AS LONG AS THE FIRST TEST. 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
    624016 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 1006247630

    Patients

    Seq Age Sex Outcome Treatment
    1