BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGG II QUANT REAGENT KIT

    MDR report key: 12206635 · Received July 21, 2021

    Report

    Report Number
    3008344661-2021-00142
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 10, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6S61-23 (SARS-COV-2 IGG II QUANT ) AND HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6S60-20/-30 (ADVISEDX SARS-COV-2 IGG II: EUA # 203119). THE COMPLAINT INVESTIGATION FOR A FALSE POSITIVE SARS-COV-2 IGG II QUANT RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, AND DEVICE HISTORY RECORDS. ADDITIONALLY, IN-HOUSE SPECIFICITY TESTING FOR REAGENT LOT 27525FN00 WAS COMPLETED. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW ON LOT 27525FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN-HOUSE SPECIFICITY TESTING FOR REAGENT LOT 27525FN00 WAS COMPLETED USING A RETAINED SAMPLE OF THE COMPLAINT LOT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. THE CUSTOMER REPORTED A POSITIVE RESULT OF 126 AU/ML FOR ONE UNVACCINATED PATIENT WHEN TESTING WAS PERFORMED WITH ALINITY I SARS-COV-2 IGG II QUANT, REAGENT LOT 27525FN00. A POSITIVE RESULT OF 131.9 AU/ML WAS REPORTED FOR THE SAME PATIENT ON ANOTHER DAY. THE PATIENT WAS NEGATIVE WHEN TESTED WITH THE ROCHE TOTAL ANTIBODY (NUCLEOCAPSID) ASSAY. THE PATIENT WAS NOT AWARE OF ANY PAST INFECTION. TESTING WAS PERFORMED AT A REFERENCE LABORATORY WITH POSITIVE RESULTS OBTAINED FOR ALINITY I SARS-COV-2 IGG II, AND NEGATIVE RESULTS OBTAINED FOR BOTH ALINITY I SARS-COV-2 IGG (NUCLEOCAPSID) AND ALINITY I SARS-COV-2 IGM (SPIKE). IN THIS CASE, THE PATIENT WAS NOT AWARE OF ANY PAST INFECTION. RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., SYMPTOMS, RESULTS OF OTHER TESTS, AND CLINICAL IMPRESSIONS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE SARS-COV-2 IGG II QUANT REAGENT LOT 27525FN00 WAS IDENTIFIED.SECTION D4 LOT NO. WAS CORRECTED FROM 27088FN00 TO 27525FN00 SECTION D4 EXPIRATION DATE WAS UPDATED FROM 09/03/2021 TO 09/26/2021 SECTUIB H4 DEVICE MFG DATE WAS UPDATED FROM 04/02/2021 TO 04/28/2021

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSE POSITIVE SARS-COV-2 IGG II QUANT RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 126 AU/ML, REPEAT WITH ROCHE = NEGATIVE, A NEW SAMPLE WAS COLLECTED A DIFFERENT DAY = 131.9 AU/ML THE PATIENT HAS NOT BEEN VACCINATED AND THERE IS NO AWARENESS OF A PAST INFECTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100150 SARS-COV-2 IGG II QUANT REAGENT KIT SARS-COV-2 LGG QKO ABBOTT IRELAND 27525FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).