BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 15492421 · Received September 27, 2022

    Report

    Report Number
    1221359-2022-04840
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    July 1, 2022
    Report Date
    December 21, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    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 INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR NO 221359-2022-04824,1221359-2022-04837 THROUGH 1221359-2022-04844.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION TO THE INVESTIGATION COMPLETION. PER (B)(6), THE CUSTOMER PERFORMED THE ID NOW COVID-19 POSITIVE NEQAS SWAB AS A QC TEST AND RECEIVED A FAILING RESULT. PER THE INVESTIGATION, THIS IS THE EXPECTED / INTENDED RESULT FOR THE POSITIVE CONTROL SWAB AS IT IS COATED WITH COVID-19 VIRUS INSTEAD OF INACTIVATED INFLUENZA A AND B VIRUSES IN THE ABBOTT CONTROL. THERE HAS BEEN NO MALFUNCTION OF THE ASSAY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION AND CORRECTIONS TO B5, H6 "MEDICAL DEVICE PROBLEM CODE". PLEASE SEE UPDATES: B5, G3, G6, H2 AND H6. THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER AND LOGFILES, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION. PLEASE SEE RELATED MFR REPORT NUMBERS: 1221359-2022-04837 THROUGH 1221359-2022-04844.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NINE (9) FALSE/UNEXPECTED RESULTS WITH THE ID NOW COVID-19 INSTRUMENT FOR MULTIPLE PATIENT SAMPLES PERFORMED ON UNKNOWN DATES AS PART OF VALIDATION STUDIES. THIS MFR. REPORT ADDRESSES FALSE RESULT FIVE (5) OF NINE (9). THE CUSTOMER REPORTED A FALSE/UNEXPECTED RESULT WITH THE ID NOW COVID-19 INSTRUMENT PERFORMED ON UNKNOWN DATES ON A PATIENT SAMPLE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NINE (9) FALSE/UNEXPECTED RESULTS WITH THE ID NOW COVID-19 INSTRUMENT FOR MULTIPLE PATIENT SAMPLES PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST RESULT FIVE (5) OF NINE (9). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 INSTRUMENT PERFORMED ON UNKNOWN DATES ON AN UNKNOWN SAMPLE TYPE. PCR CONFIRMATION TESTING WAS PERFORMED WITH AUS DIAGNOSTICS PLATFORM AND GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363329 ID NOW COVID 19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown