BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14336397 · Received May 9, 2022

    Report

    Report Number
    1221359-2022-02409
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    February 11, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INITIAL REPORTER ADDRESS EXCEEDS CHARACTER LIMIT: (B)(6). SIMILAR PRODUCT TO 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. RELATED MFR REPORT NUMBERS: 1221359-2022-02407 THROUGH 1221359-2022-02435.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M170683 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 KIT PART NUMBER 191-000 / LOT M170683 AND TEST BASE PART NUMBER 190-430 / LOT M170683. 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 M170683 SHOWED THAT THE COMPLAINT RATE IS 0.04%. IN CONCLUSION, RETENTION TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QC SAMPLES AND MANUFACTURING BATCH RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE. REVIEW OF COMPLAINTS AGAINST THE KIT LOTS FOR THE REPORTED ISSUE INDICATED PRODUCT PERFORMANCE IS AS EXPECTED AND DID NOT IDENTIFY A PRODUCT DEFICIENCY. ABBOTT DIAGNOSTICS SCARBOROUGH 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. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWENTY-NINE (29) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON VARIOUS DATES. THIS REPORT ADDRESSES PATIENT THREE (3) OF TWENTY-NINE (29) AND LOT NUMBER M170683 (TOTAL QUANTITY 15). THE CUSTOMER REPORTED A POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASOPHARYNGEAL SWAB. PCR CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2022 USING NASOPHARYNGEAL AND OROPHARYNGEAL SAMPLES WHICH GENERATED NEGATIVE RESULTS. NO FURTHER INFORMATION REGARDING PATIENT HEALTH AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823130 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M170683 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Female