BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12099720 · Received July 1, 2021

    Report

    Report Number
    1221359-2021-01865
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    May 5, 2021
    Report Date
    July 15, 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
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE INVESTIGATION CONCLUSION AND ADDITIONAL INORMATION. INVESTIGATION CONCLUSION : IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS WOULD NOT FIT. LOT 1035 - 1039, (B)(6). INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1018840 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 1018840, TEST BASE PART NUMBER 190-430 / LOT 1018840. 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 1018840 SHOWED THAT THE COMPLAINT RATE IS (B)(4).

    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 DIRECT TESTED NASOPHARYNGEAL SWAB. THE CUSTOMER REPORTED THAT THE PATIENT WAS REQUIRED TO TAKE THE RAPID TEST PRIOR TO ADMISSION. ON (B)(6) 2021, THE PATIENT WAS ADMITTED FOR A MISCARRIAGE AND SCHEDULED FOR A DILATION AND CURETTAGE (D&C) PROCEDURE AT KKM MIRI ( REFERRED TO AS THE COMPANY ). UPON RECEIVING THE PATIENT'S POSITIVE RESULTS AN AMBULANCE WAS ARRANGED TO TRANSPORT THE PATIENT TO MIRI GENERAL HOSPITAL WARD 4 (REFERRED TO AS "GH") FOR QUARANTINE. REPEAT TESTING WAS NOT PERFORMED. RT- PCR CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 AT THE COMPANY USING THE NASOPHARYNGEAL SWAB SAMPLE AND NEGATIVE RESULTS WERE PROVIDED ON (B)(6) 2021. DUE TO THE PATIENT'S DAY 2 RT-PCR RESULTS COMING BACK NEGATIVE, THE PATIENT WAS TRANSFERRED TO THE GH'S PUI WARD 10 SINCE ALREADY BEING EXPOSED TO CONFIRMED COVID POSITIVE PATIENTS. THE PATIENT HAD TO GO THROUGH TWO MORE ROUNDS OF COVID RT-PCR SWABS DUE TO BEING STILL EXPOSED TO HIGH RISK POTENTIAL PUI PATIENTS ON WARD 10. THE CUSTOMER REPORTED THAT ALL THE PATIENT'S RT-PCR TEST WERE NEGATIVE. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER REPORTED THAT THE PATIENT WAS IMPACTED DUE TO THE FALSE POSITIVE TEST RESULT BY BEING ADMITTED TO THE COVID-19 WARD AND BEING EXPOSED TO OTHER COVID-19 PATIENTS. IN ADDITION, THE PATIENT'S FAMILY MEMBERS AND CLOSE CONTACT WERE FORCED TO UNDERGO COVID-19 PCR TEST (ALL TESTED NEGATIVE) AND UNNECESSARY QUARANTINE, WITH NEGATIVE IMPACT EMOTIONALLY AND FINANCIALLY. AS THE DIRECT PARTY PATIENT SELF, SHE COULD POTENTIALLY DEVELOP PTSD (POST TRAUMATIC STRESS DISORDER) AND/OR DEPRESSION IN THE NEAR FUTURE. NO TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000161 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1018840 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR