BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13941001 · Received March 29, 2022

    Report

    Report Number
    1221359-2022-01591
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 3, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 190-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. REFERENCE MFR NUMBERS: 1221359-2022-01592.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M180239 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART 190-000J / LOT M180239 AND TEST BASE PART NUMBER 190-430 / LOT M180239. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS WITH NO FALSE POSITIVE RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED, AND CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE, HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2022 . PER CUSTOMER, THE PATIENT BECAME OLIGURIC A MONTH AGO, HAD A CATHETER PLACED AND URINE WAS BROWN. COAGULA AND HEMATURIA WERE SHOWN . CONFIRMATION TESTING WAS PERFORMED WITH THE SMART GENE (MIZUHO MEDY) ANALYSIS INSTRUMENT WITH A NEGATIVE RESULT. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748003 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M180239 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female LAXATIVE