BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10796312 · Received November 5, 2020

    Report

    Report Number
    1221359-2020-00360
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    September 26, 2020
    Report Date
    December 8, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS PROVIDED FROM ABBOTT DIAGNOSTICS (B)(4), INC.'S INVESTIGATION. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M126133 SHOWED THAT THE COMPLAINT RATE IS (B)(4).

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M126133 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT M126133 AND TEST BASE PART NUMBER 190-430 / LOT M126133 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM CICU THAT (3) ALARIS PUMPS GAVE THE ERROR MESSAGE "CHANNEL COMMUNICATION ERROR" DURING LINE CHANGE, AND THERE WAS NO PATIENT IMPACT. PUMP ASSET TAG ID'S WERE CS1178, CS0393, CS0745, HOWEVER THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED, AND THE PCU ID WAS UNKNOWN. ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255302 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M126133 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1