BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13759486 · Received March 14, 2022

    Report

    Report Number
    1221359-2022-01551
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 17, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INFORMATION FROM THE CUSTOMER, THERE WAS ONLY ONE FALSE POSITIVE RESULT AND NOT TWO AS INITIALLY REPORTED. RELATED REPORT MFR. REFERENCE 1221359-2022-01552 HAS BEEN CORRECTED. INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M173969 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: M173969, TEST BASE PART NUMBER 190-430 / LOT: M173969. 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 M173969 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE; SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 191-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-01552.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFOREMD ON (B)(6)2022. CONFIRMATION TESTING VIA AN UNKNOWN RT-PCR PLATFORM GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY. THIS REPORT IS ONE (1) OF TWO (2) AND ADDRESSES LOT M173969. THE CUSTOMER REPORTED ONE FALSE POSITIVE WITH THE IDNOW COVID-19 ASSAY (COLLECTION DATE: (B)(6) 2022). CONFIRMATION TESTING VIA AN UNKNOWN RT-PCR PLATFORM GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281572 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M173969 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown