BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11700514 · Received April 21, 2021

    Report

    Report Number
    1221359-2021-01187
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 20, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION NARRATIVE (H10). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1013556 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 191-000 / LOT 1013556, TEST BASE PART NUMBER 190-430 / LOT 1013556. 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 1013556 SHOWED THAT THE COMPLAINT RATE IS 0.01%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER IT COULD BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    REFERENCE REPORTS: 1221259-2021-01177, 1221359-2021-01178, AND 1221359-2021-01179. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES THIS MFR. REPORT ADDRESSES EVENT FOUR (4) OF FOUR (4). THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 WITH DIRECT TESTED DEEP NASAL AND PHARYNGEAL SAMPLES COLLECTED WITH CITOSWAB TRANSPORT SWABS VISCOSE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON DEEP NASAL AND PHARYNGEAL SWAB WITH PCR GENERATED NEGATIVE RESULTS; CT VALUES NOT PROVIDED. PER THE CUSTOMER, IN A CASE POSTPONEMENT OF AN ACCIDENT SURGERY OPERATION BY APPROX. 3 DAYS THERE WAS NO REDUCTION OF THE MEDICAL QUALITY. IT IS UNKNOWN WHICH EVENT IS RELATED TO THIS SURGICAL DELAY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598246 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013556 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1