BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14115531 · Received April 14, 2022

    Report

    Report Number
    1221359-2022-01864
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 16, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-01856 THROUGH 1221359-2022-01875.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063392 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 NUMBER 190-000 / LOT 1063392, TEST BASE PART NUMBER 190-430 / LOT 1063392. 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 1063392 SHOWED THAT THE COMPLAINT RATE IS (B)(4) (21/53664). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, A POSSIBLE ROOT CAUSE IS CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWENTY (20) FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 PERFORMED ON (B)(6) 2022 INVOLVING LOT NUMBER (1063392) TOTAL QUANTITY (1). PER CUSTOMER,NONE OF THE PATIENTS WERE SYMPTOMATIC. THIS REPORT ADDRESSES TEST NINE (9) OF TWENTY (20) TESTS . CONFIRMATION TESTING ON NASAL SWAB WITH ANOTHER ID NOW INSTRUMENT WAS A POSITIVE RESULT. CT VALUES NOT PROVIDED. NO ADDITIONAL PATIENT INFORMATION,INCLUDING TREATMENT AND OUTCOME,WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648926 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1063392 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown