BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12922310 · Received December 3, 2021

    Report

    Report Number
    1221359-2021-03625
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 5, 2021
    Report Date
    August 23, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G6, H2 AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M160774 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 M160774 AND TEST BASE PART NUMBER 190-430 / LOT M160774 . 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 M160774 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN ADDITION, A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M159271 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW (BRR) REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE, AND REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES THAT THE PRODUCT IS PERFORMING ACCORDING TO THE STATEMENTS CONTAINED IN THE PACKAGE INSERT AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS UPDATED BASED ON THE LOT TRACE CALCULATION. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M160774 SHOWED THAT THE COMPLAINT RATES ARE 0.009% (UPDATED FROM 0.01%) AND 0.01%, RESPECTIVELY.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED (2) TWO CONFLICTING RESULTS WITH THE PANBIO ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON (B)(6) 2021 AND (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT 2 OF 2. THE CUSTOMER REPORTED (1) CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL SAMPLE FLOCKED TIP SWAB. THE CUSTOMER REPORTED THAT THE FIRST ID NOW COVID-19 ASSAY GENERATED A POSITIVE RESULT. A SECOND PANBIO COVID-19 AG RAPID TEST KIT WAS USED WITH A NASOPHARYNGEAL, OBTAINED NEGATIVE RESULT. THE THIRD TEST KIT VAZYME SARS-COV-2 TEST WAS PERFORMED ON A NASOPHARYNGEAL, OBTAINED A NEGATIVE RESULT. THE FOURTH TEST USED WAS A SECOND ID NOW COVID-19 TEST ASSAY, ALSO OBTAINED NEGATIVE RESULT. THE CUSTOMER IS STILL AWAITING PCR CONFIRMATION RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823817 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M160774 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown