BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT MOLECULAR, INC. ALINITY M SARS-COV-2 ASSAY

    MDR report key: 13654638 · Received March 2, 2022

    Report

    Report Number
    3016605234-2022-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    January 5, 2022
    Report Date
    March 2, 2022
    Manufacturer
    ABBOTT MOLECULAR INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR SUBMISSION IS IN RESPONSE TO MEDWATCH LETTERS MW5106796 AND MW5106797 THAT WERE RECEIVED BY CURATIVE ON (B)(6) 2022. UPON REVIEWING MEDWATCH LETTERS MW5106796 AND MW5106797, IT WAS FOUND THAT THE COMPLAINANT NAME, DESCRIPTION, AND KIT ID (BARCODE) WERE IDENTICAL. THE ONLY DIFFERENCE ASIDE FROM THE MEDWATCH REPORT # IS THE DATE OF EVENT. MW5106796 HAS A DATE OF EVENT OF (B)(6) 2022 AND MW5106797 HAS A DATE OF EVENT OF (B)(6) 2022. SINCE THE TWO MEDWATCH LETTERS REFER TO THE SAME KIT ID (BARCODE), ONE MDR IS BEING SUBMITTED. FROM OUR PRELIMINARY INVESTIGATION, IT WAS FOUND IN CURATIVE'S PATIENT DATABASE THAT THE COMPLAINANT CORRESPONDING TO THE BARCODE LISTED IN BOTH MEDWATCH LETTERS TESTED ONCE ON (B)(6) 2022 AT 03:07PM PST. THE COMPLAINANT'S RESULT WAS RESULTED ON (B)(6) 2022 AT 04:54AM PST. THE COMPLAINANT'S RESULT CAME BACK NEGATIVE. NO CORRECTIONS WERE MADE UPON RELEASE OF THE RESULTS. PER THE CLINICAL LAB'S INVESTIGATION, THE PATIENT'S SAMPLE WAS RESULTED CORRECTLY. THE PATIENT'S SAMPLE, (B)(4), WAS LOCATED ON PLATE- (B)(4) AT POSITION F11. THE PATIENT'S SAMPLE YIELDED A VIRAL CT VALUE OF N/A (INFINITY) MEANING THE VIRUS WAS NOT DETECTED IN THE SAMPLE. A FLOATING BLANK WAS LOCATED IN WELL D4 - THIS SERVES AS A SECONDARY PLATE IDENTIFIER TO AID IN RULING OUT SWITCHED PLATES BEFORE RESULTS ARE REPORTED. IN THIS INSTANCE, THE FLOATING BLANK YIELDED A VIRAL CT VALUE OF N/A (INFINITY) WHICH IS CONSIDERED ACCEPTABLE AND SHOWS THAT NO PLATES WERE SWITCHED DURING THE PROCESSING OF THE PATIENT'S SAMPLE. FURTHER INVESTIGATION SHOWS THAT THE QUALITY CONTROL MATERIAL FOR THE POSITIVE AND NEGATIVE CONTROLS PASSED AND WERE NOT EXPIRED AND THAT THE POSITIVE CONTROLS RESULTED AS POSITIVE. MOREOVER, PLATE- (B)(4), WHICH CONTAINED THE PATIENT'S SAMPLE, YIELDED SEVERAL POSITIVE RESULTS. THE LOT NUMBERS FOR THE POSITIVE CONTROLS WERE (B)(4) AND (B)(4). NEGATIVE CONTROLS USED WERE (B)(4) AND (B)(4). IN CONCLUSION, CURATIVE CANNOT CONFIRM THE PATIENT'S CLAIM OF FALSE NEGATIVE. THE RESULTS OF THE INVESTIGATION CLEARLY SHOWED A TRUE NEGATIVE RESULT.

    Description of Event or Problem · 0

    MEDWATCH LETTERS MW5106797 (DATE OF EVENT (B)(6) 2022) AND MW5106796 (DATE OF EVENT (B)(6) 2022).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565291 ABBOTT MOLECULAR, INC. ALINITY M SARS-COV-2 ASSAY NASAL COLLECTION SWAB KIT (ABBOTT ALINITY) QJR ABBOTT MOLECULAR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female