BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11792918 · Received May 7, 2021

    Report

    Report Number
    1221359-2021-01396
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    March 30, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE REPORTS: 1221359-2021-01394, 1221359-2021-01395, 1221359-2021-01397, 1221359-2021-01398, 1221359-2021-01399, 1221359-2021-01400. (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1022277 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:1022277, TEST BASE PART NUMBER 190-430 / LOT: 1022277. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1022277 SHOWED THAT THE COMPLAINT RATE IS (B)(4) FOR BOTH. ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. REFERENCE REPORTS: 1221359-2021-01394, 1221359-2021-01395, 1221359-2021-01397, 1221359-2021-01398, 1221359-2021-01399, 1221359-2021-01400.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT THREE (3) OF SEVEN (7). THE CUSTOMER REPORTED THE FOLLOWING SEQUENCE OF TESTING ON AN UNKNOWN SWAB TYPE WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021.THE INITIAL TEST GENERATED A POSITIVE RESULT. A SECOND TEST ON ANOTHER ID NOW COVID-19 INSTRUMENT GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED WHEN A RESULT IS POSITIVE WITH ONE ID NOW INSTRUMENT, THEY REPEAT THE TEST WITH THEIR SECOND ID NOW INSTRUMENT. IT WAS ALSO REPORTED, IF THE RESULT IS POSITIVE WITH THE SECOND ID NOW, THEY SEND THE SAMPLE FOR PCR AND THEY NEVER HAD FALSE POSITIVE RESULT SO FAR. THE CUSTOMER CONTINUED TO STATE THAT IF THE RESULT IS NEGATIVE WITH THE SECOND ID NOW, THEY DECONTAMINATE THE FIRST ID NOW WHERE THE POSITIVE RESULT WAS OBTAINED AND PROVIDE NEGATIVE RESULT ASSUMING THE DISCREPANT RESULT WAS DUE TO A CONTAMINATION OF THE INSTRUMENT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687776 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022277

    Patients

    Seq Age Sex Outcome Treatment
    1