BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 15402840 · Received September 12, 2022

    Report

    Report Number
    1221359-2022-04460
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 28, 2022
    Report Date
    November 18, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE MENTIONED IN THIS SECTION IS APPROXIMATE, THE PATIENT HAS NOT PROVIDED THE EVENT DATE. 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 INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REF MFR REPORT: 1221359-2022-04459 THROUGH 1221359-2022-04461.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE UPDATED INFORMATION AS WELL AS CORRECT THE DATE OF OCCURRENCE. PLEASE REFER TO B3 AND B5 FOR CORRECTED DATES AND UPDATED INFORMATION. PLEASE SEE UPDATED FIELDS: B4, D4, G3 AND H4. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED, THIS REPORT ADDRESSES FALSE POSITIVE IS TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON UNKNOWN DATE & SAMPLE. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED BETWEEN (B)(6) 2022 TO (B)(6) 2022 USING TWO LOTS (1073378 AND 1073255). THIS REPORT ADDRESSES FALSE POSITIVE RESULT TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022 USING A KITTED THROAT SWAB SAMPLE. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, REGARDING PATIENT TREATMENT OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359569 ID NOW COVID 19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1073378 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown