BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 8755220 · Received July 2, 2019

    Report

    Report Number
    8020790-2019-00036
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    May 24, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE VIDAS® CMV IGM LOT: 1006946280 / 191004-0. QUALITY CONTROL RECORDS: NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR VIDAS CMV IGM 1006946280 / 191004-0) FOR A BAD CORRELATION. NO CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) NOR NON-CONFORMITY WAS RELATED TO THE CLIENT'S ISSUE. NO ANOMALY WAS LINKED TO THE CUSTOMER COMPLAINT DURING ANALYSIS OF MANUFACTURE AND CONTROL. CONTROL CHARTS ALANYSIS: EIGHT INTERNAL SAMPLES ANALYZED ON SEVEN LOTS INCLUDING THE CUSTOMER'S LOT VIDAS CMV IGM LOT: 1006946280 / 191004-0. ALL RESULTS WERE WITHIN EXPECTED SPECIFICATIONS, AND THIS BATCH WAS IN THE TREND OF OTHER LOTS. TESTS PERFORMED BY COMPLAINT LABORATORY: SAMPLES WERE SELECTED CLOSE TO THE PATIENT SAMPLE RESULT CONCERNED BY THIS COMPLAINT: CM40 TARGET 1.34 VT - RANGE [0.95-1.73] VT, COMPLAINT LAB RESULT 04JUL2019 : 1.54 VT, QUALITY CONTROL RESULT 11DEC2018 : 1.35 VT, CM53 TARGET 1,.5 VT - RANGE [1.5-2.41] VT, COMPLAINT LAB RESULT 04JUL2019 : 2.16 VT, QUALITY CONTROL RESULT 11DEC2018 : 1.86 VT, CM79 TARGET 1.34 VT- RANGE [0.95-1.7.] VT, COMPLAINT LAB RESULT 04JUL20.9 : 1.36 VT, SAMPLE CM79 NOT TESTED BY QUALITY CONTROL FOR THIS BATCH. ALL THE RESULTS WERE IN THEIR EXPECTED RANGE WITHOUT ANY SEROLOGICAL INTERPRETATION CHANGE. THE COMPARISON BETWEEN THESE RESULTS AND THE CONTROL OF ACTIVITY , BEFORE THE RELEASE, DID NOT SHOW ANY SIGNIFICATIVE EVOLUTION OF THE VIDAS CMV IGM LOT: 1006946280 / 191004-0. VIDAS 3 LOGS ANALYSIS: THE LOG FILES ANALYSIS SHOWS THAT THERE IS NO ISSUE ON THE INSTRUMENT REGARDING: THE TEMPERATURES OF THE LOADING BAY AND SECTIONS, THE PIPETTOR ASPIRATIONS/DISTRIBUTION, THE SECTION PUMPS. THE SCANNER HEAD. AN ISSUE WAS DETECTED ONLY DURING THE USE OF THE STRIP FOR THE SAMPLE "BMX_ANONYM000368" AND CMVM ASSAY ON 24 MAY 2019. THIS INFORMATION SHOWS THERE WAS NO ISSUE WITH THE SCANNER HEAD (NO INSTRUMENT ANOMALY), BUT RATHER AN ISSUE WITH THE STRIP USED ON 24MAY2019 WHICH MAY HAVE BEEN FROM A BAD INSERTION OR BROKEN TAB. CONCLUSION: CUSTOMER'S ISSUE WAS NOT REPRODUCED INTERNALLY. A PUNCTUAL ANOMALY WITH THE STRIP USED ON 24MAY2019 WAS NOTED WITHOUT AN EXPLANATION FOUND. MAIN HYPOTHESIS: THE TEST RESULT DATA (NEGATIVE TV) AND RFV OBSERVED (TV = - 0,08 / -75 RFV ) FOR THE FALSE RESULT ARE IN FAVOR OF AN ANOMALY LINKED TO THE POSITIONING OF THE STRIP (BAD INSERTION OR BROKEN TAB). NO INSTRUMENT ANOMALY WAS FOUND. ACCORDING TO ALL THE DATA ABOVE, VIDAS CMV IGM LOT: 1006946280 / 191004-0 PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE (B)(6) VIDAS® CMV IGM RESULT FOR A PREGNANT WOMAN. REPEAT TEST OBTAINED A (B)(6) RESULT. ALTERNATE METHOD (ARCHITECT) ALSO OBTAINED A (B)(6) RESULT. THE CUSTOMER INDICATED THE FOLLOWING RESULTS FOR TWO (2) DIFFERENT SAMPLES DURING THREE (3) TESTING SESSIONS. SAMPLE (B)(6) (COLLECTION DATE (B)(6) 2019) TESTED THE (B)(6) ON POSITION A3; (B)(6) ON BATCH 191004-0. SAMPLE (B)(6) (COLLECTION DATE (B)(6) 2019) TESTED THE (B)(6) ON POSITION C1; (B)(6) ON BATCH 191220-1. SAMPLE (B)(6) (COLLECTION DATE (B)(6) 2019) TESTED AGAIN THE (B)(6) ON POSITION A1; (B)(6) ON BATCH 191220-1. THE CUSTOMER INDICATED THAT THE INITIAL (B)(6) RESULT WAS REPORTED TO THE PHYSICIAN. HOWEVER, THE PATIENT WAS NOT HARMED IN ANY WAY, AND WAS NOT TREATED INAPPROPRIATELY. ALTHOUGH PRODUCT REFERENCE 30205 IS NOT SOLD/DISTRIBUTED IN THE UNITED STATES, A SIMILAR PRODUCT IS (REFERENCE 30205-01). BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546271 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 1006946280

    Patients

    Seq Age Sex Outcome Treatment
    1