BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 12226525 · Received July 27, 2021

    Report

    Report Number
    1221359-2021-02111
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 20, 2021
    Report Date
    December 8, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1025380 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 1025380 , TEST BASE PART NUMBER 190-430 / LOT 1025380 . 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 1025380 SHOWED THAT THE COMPLAINT RATE IS(B)(4).. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED FOR INVESTIGATION , HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A SWAB (G1022FN ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO). ON THE SAME DAY PCR CONFIRMATION TESTING GENERATED A NEGATIVE RESULT. (PLATFORM: ALINITY). PATIENT HAS HOSPITALIZED ON (B)(6) 2021, FOLLOW-UP CARE AND REHABILITATION AFTER FALL WITH FRACTURE OF THE LEFT HUMERAL HEAD AND NON-DISPLACED FRACTURE OF THE LEFT ISCHIO PUBIC BRANCH. AND PATIENT HAD LEFT THE HOSPITAL TO GO TO NURSING HOME ON (B)(6) 2021 CUSTOMER CONFIRMED PATIENT WAS NOT SYMPTOMATIC. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS UNDER MEDICAL THERAPY USING LOVENOX (B)(6) 2021, AUDISPRAY ADULT (B)(6) 2021, CALCIDOSE VITAMINE D (B)(6) 2021, CETIRIZINE (B)(6) 2021,DOLIPRANE (B)(6) 2021, MOTELUKAST (B)(6) 2021, MOVICOL (B)(6) 2021, BETNEVAL (B)(6) 2021, KETOCONAZOLE (B)(6) 2021, NASOCORT (B)(6) 2021, TRIMBOW (B)(6) 2021. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER MENTIONED THERE WAS A DELAY FOR ADMISSION TO NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127500 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1025380 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female