BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12105145 · Received July 1, 2021

    Report

    Report Number
    1221359-2021-01877
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    May 30, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS MADE TO B1, B2, E1, H1, H6. UPON REVIEW OF THE CASE, IT WAS IDENTIFIED THAT DEATH WAS INADVERTANTLY SELECTED ON FOLLOW-UP #1. REFERENCE MFR. REPORTS: 1221359-2021-01872, 1221359-2021-02260, 1221359-2021-02261, 1221359-2021-02262.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M140253 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 TEST BASE PART NUMBER (B)(4) / LOT M140253. 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 (B)(4). 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. REFERENCE MFR NUMBER: 1221359-2021-01872. 1221359-2021-01877.

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REFERENCE MANUFACTURE NUMBER: 1221359-2021-01872. INITIAL REPORTER NAME: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT FOUR (4) OF FOUR (4).. THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON DIRECT TESTED NASOPHARYNGEAL KITTED SWAB. THE ID NOW COVID-19 WAS USED TO TEST FOUR OUTPATIENT POLYCLINIC FOR PRE-SURGERY AS ROUTINE PATIENT TESTING. ALL FOUR RESULT FROM FOUR PATIENT WERE POSITIVE ID NOW COVID-19 HOWEVER DUE TO ALL PATIENT ASYMPTOMATIC THE LAB INFORMED THAT THE TEST RESULT USING ID NOW COVID-19 WERE INVALID AND DECIDED TO RE-TAKE THE SWAB FOR PCR TEST WITHIN 1 HOUR AFTER THE ID NOW SWAB. THE PCR SWAB RESULTS FOR THE FOUR PATIENTS WERE ALL NEGATIVE AND THE PATIENTS WERE IMMEDIATELY TREATED ACCORDING TO THE REGULAR NON-COVID PROTOCOL. NO ADDITIONAL PATIENT INFORMATION INCLUDING. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001541 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCABOROUGH M140253 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Death