BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGM

    MDR report key: 12575994 · Received October 5, 2021

    Report

    Report Number
    2122870-2021-00159
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 5, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGM REAGENT WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF OTHER INSTRUMENT ISSUES. THERE WERE NO REPORTS OF OTHER ISSUES WITH THIS ASSAY. ARCDATA ANALYSIS FOR THE CSV DATA FILE PROVIDED DID NOT HIGHLIGHT A PERFORMANCE ISSUE. CEX, PEX AND LEX FLAGS WERE OBSERVED MEANING THAT CALIBRATION WAS EXPIRED, OPEN PACK STABILITY TIME HAD ELAPSED FOR THE REAGENT PACK AND THE REAGENT LOT WAS EXPIRED. THE CUSTOMER WAS RECOMMENDED TO CLEAN THE INSTRUMENT. A NORMAL PREVENTIVE MAINTENANCE (PM) WAS SCHEDULED FOR THE INSTRUMENT. DURING THIS PM, THE CUSTOMER CHECKED THE INSTRUMENT TECHNICAL STATE AND NO ISSUE WAS DETECTED. THE CUSTOMER WAS RETRAINED ON HOW TO PERFORM MAINTENANCE. ALTHOUGH A USE ERROR IS SUSPECTED AS THE CUSTOMER MAY NOT CLEAN THE ASPIRATE PROBES PROPERLY AND IS USING EXPIRED MATERIAL, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT. NOTE: NO UDI AND NO MANUFACTURED DATE COULD BE PROVIDED AS NO LOT NUMBER WAS SUPPLIED.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED ONE NON-REPEATABLE ERRONEOUSLY ELEVATED SARS-COV-2 IGM PATIENT RESULT (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER WAS NOT SUPPLIED) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). ON (B)(6) 2021, THE SARS-COV-2 IGM INITIAL RESULT WAS 1.67 S/CO (REACTIVE). UPON REPEAT TWICE THE RESULTS WERE 0.16 S/CO (NON-REACTIVE). NO FURTHER INFORMATION WAS PROVIDED. NO INFORMATION REGARDING PATIENT CLINICAL FILE WAS PROVIDED (PCR, SYMPTOMS OR VACCINATION INFORMATION NOT PROVIDED). NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON 31AUG2021 WITH REAGENT LOT 172053 AND CALIBRATOR LOT 922828. ARCDATA ANALYSIS FOR THE CSV DATA FILE PROVIDED DID NOT HIGHLIGHT A PERFORMANCE ISSUE. CEX, PEX AND LEX FLAGS WERE OBSERVED MEANING THAT CALIBRATION WAS EXPIRED, OPEN PACK STABILITY TIME HAD ELAPSED FOR THE REAGENT PACK AND THE REAGENT LOT WAS EXPIRED. THE CUSTOMER WAS RECOMMENDED TO CLEAN THE INSTRUMENT. A NORMAL PREVENTIVE MAINTENANCE (PM) WAS SCHEDULED FOR THE INSTRUMENT. DURING THIS PM, THE CUSTOMER CHECKED THE INSTRUMENT TECHNICAL STATE AND NO ISSUE WAS DETECTED. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, CENTRIFUGATION, STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476370 ACCESS SARS-COV-2 IGM IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO

    Patients

    Seq Age Sex Outcome Treatment
    1