BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGG ASSAY

    MDR report key: 9207410 · Received October 18, 2019

    Report

    Report Number
    8020790-2019-00061
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Report Date
    February 26, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFZ
    PMA / PMN Number
    K920661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR AN ITALIAN CUSTOMER'S COMPLAINT OF OBTAINING A FALSE NEGATIVE RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® CMV IGG (CMVG) ASSAY (REF. 30204, LOT 1007219730). THE CUSTOMER (A MINI VIDAS® USER) OBTAINED A NEGATIVE RESULT WHEN TESTING A PATIENT'S SAMPLE ON VIDAS CMVG BATCH 1007219730 / 200206-0 WHILE THE SAMPLE WAS FOUND POSITIVE WITH IMMULITE® FROM ABBOTT AND LIAISON® FROM DIASORIN. THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR SUBMISSION OF THE PATIENT SAMPLE. THE INVESTIGATION INCLUDED COMPLAINT TREND ANALYSIS, A REVIEW OF QUALITY CONTROL RECORDS, A CONTROL CHARTS ANALYSIS, AND TESTING OF INTERNAL SAMPLES WITH THE IMPACTED LOT. INVESTIGATION RESULTS: COMPLAINT TRENDING ANALYSIS: ONLY ONE OTHER COMPLAINT HAS BEEN RECORDED FOR PERFORMANCE ISSUES ON VIDAS CMVG BATCH 1007219730 / 200206-0. THIS COMPLAINT FOR BAD CORRELATION WAS CLEARLY LINKED TO AN OPERATOR'S ERROR. QUALITY CONTROL RECORDS: THE ANALYSIS OF VIDAS CMVG BATCH 1007219730 / 200206-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES IN RELATION WITH THE OBJECT OF THIS COMPLAINT. THERE IS NEITHER CAPA NOR NON-CONFORMITY LINKED TO THE OBJECT OF THIS ISSUE. CONTROL CHARTS ANALYSIS: ANALYSIS PERFORMED ON: FOUR INTERNAL SAMPLES, INCLUDING THREE SAMPLES WITH A POSITIVE INTERPRETATION AND ONE WITH A NEGATIVE INTERPRETATION. SEVEN VIDAS CMV IGG BATCHES INCLUDING THE CUSTOMER'S LOT CMV IGG BATCH 1007219730 / 200206-0. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED INTERNALLY: ON INTERNAL SAMPLES THE COMPLAINTS LABORATORY TESTED FOUR INTERNAL SAMPLES (THREE POSITIVE ONES AND ONE NEGATIVE) ON THE RETAIN KIT VIDAS CMV IGG LOT 1007219730/200206-0 ALL THEIR RESULTS WERE WITHIN ACCEPTABLE RANGES WITHOUT SIGNIFICANT CHANGE COMPARED TO THOSE OBTAINED BEFORE THE BATCH RELEASE. ADDITIONAL TESTS WERE PERFORMED ON VIDAS CMV IGG LOT 1007219730 / 200206-0 USING AN INTERNAL POSITIVE SAMPLE. THE FIRST ONE WAS CARRIED OUT BY DISPENSING AN INSUFFICIENT VOLUME OF SAMPLE (50 L INSTEAD OF 100 L) AND LED TO A SIMILAR POSITIVE RESULT THAN IF A CORRECT VOLUME IS DISPENSED. THE SECOND TEST WAS CARRIED OUT WITHOUT ANY SAMPLE DISPENSING AND A NEGATIVE RESULT WAS OBTAINED. CONCLUSION: THE INVESTIGATION DID NOT REPRODUCE THE NEGATIVE RESULTS OBSERVED BY THE CUSTOMER WHEN TESTING INTERNAL POSITIVE SAMPLES ON THE VIDAS CMV IGG LOT MENTIONED BY THE CUSTOMER (1007219730 / 200206-0). THE ONLY TIME THE COMPLAINT LABORATORY OBTAINED A NEGATIVE RESULT WAS DURING A VIDAS CMV IGG TEST CARRIED OUT WITHOUT ANY SAMPLE DISPENSING. HOWEVER, THIS OPTION WAS EXCLUDED BECAUSE A NEGATIVE RESULT WAS OBTAINED AT THE CUSTOMER'S SITE AND IN THE HOSPITAL. WITHOUT PATIENT SAMPLE RETURN, FURTHER THE INVESTIGATION TO EXPLAIN THIS NEGATIVE RESULT CANNOT BE PURSUED. BASED ON THE INFORMATION MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS CMV IGG LOT 1007219730 / 200206-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS CMV IGG (CMVG) ASSAY (REF. 30204, LOT 1007219730). THE CUSTOMER STATED THAT THE PATIENT IS DIAGNOSED WITH SEVERE HEMOLITYC ANEMIA. TESTING WAS PERFORMED VIA MULTIPLE METHODS. IMMULYTE INSTRUMENT (ABBOTT): POSITIVE RESULTS (7.65 IU/ML) FOR CMVG AND POSITIVE RESULTS (1.55 AND 1.44 IU/ML) FOR CMV IGM (CMVM). MINIVIDAS: NEGATIVE RESULTS (<4 IU/ML) FOR CMVG AND POSITIVE RESULTS (1.8 AND 1.82 IU/ML) FOR CMVM. LIAISON INSTRUMENT (DIASORIN): POSITIVE RESULTS FOR BOTH CMVG (50.9 IU/ML) AND CMVM (108 IU/ML). VIDAS (AT A DIFFERENT LABORATORY): NEGATIVE RESULTS (<4 IU/ML) FOR CMVG AND POSITIVE RESULTS FOR CMVM (VALUES NOT PROVIDED). TO SUMMARIZE, NEGATIVE RESULTS WERE ONLY OBTAINED BY THE VIDAS TESTING. THE CUSTOMER STATED THAT THE VIDAS CMV IGG RESULTS WERE NOT PROVIDED TO THE PHYSICIAN; THE DISCREPANT RESULTS HAD NO IMPACT ON PATIENT TREATMENT DECISIONS. PRODUCT REFERENCE 30204 IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THE U.S. SIMILAR PRODUCT IS REFERENCE 30204-01. INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004385 VIDAS® CMV IGG ASSAY VIDAS® CMV IGG ASSAY LFZ BIOMERIEUX SA 1007219730

    Patients

    Seq Age Sex Outcome Treatment
    1