BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14361844 · Received May 11, 2022

    Report

    Report Number
    1221359-2022-02290
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    March 29, 2022
    Report Date
    December 6, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR PRODUCT TO 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063017 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 KIT PART NUMBER 191-000 / LOT 1063017 AND TEST BASE PART NUMBER 190-430 / LOT 1063017. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1063017 SHOWED THAT THE COMPLAINT RATE IS(B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE DELETED PRIOR TO EXPORT. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 (LOT #). ADDITIONALS: D4 (EXP. DATE) AND H4. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2022 DUE TO GASTROINTESTINAL BLEEDING. THE PATIENT WAS TESTED WITH THE ID NOW COVID-19 ASSAY ON A NASOPHARYNGEAL SAMPLE ON (B)(6) 2022 WHICH PRESENTED A POSITIVE RESULT. THE PATIENT WAS KEPT SEPARATE FROM OTHER PATIENTS UNTIL CONFIRMATORY TESTING WAS COMPLETED. CONFIRMATORY PCR TESTING WAS PERFORMED (B)(6) 2022 WHICH GENERATED A NEGATIVE RESULT (PLATFORM AND SAMPLE TYPE UNKNOWN). NO TREATMENT DECISIONS WERE MADE BASED ON THE ID NOW TEST RESULT. NO FURTHER INFORMATION REGARDING HEALTH STATUS OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277615 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063017 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female