BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14269653 · Received May 3, 2022

    Report

    Report Number
    3016605234-2022-00003
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 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 LETTER MW5108961 THAT WAS RECEIVED BY CURATIVE ON 4/22/2022. FROM OUR PRELIMINARY INVESTIGATION, IT WAS FOUND IN CURATIVE'S PATIENT DATABASE THAT THE PATIENT ONLY TESTED ONCE ON (B)(6) 2022 AT 12:41PM PST. THE PATIENT'S TEST WAS RESULTED ON (B)(6) 2022 AT 03:55PM PST. THE PATIENT'S TEST RESULTED IN A NEGATIVE. NO CORRECTIONS WERE MADE TO THE PATIENT'S TEST RESULT UPON RELEASE. PER THE CLINICAL LAB'S INVESTIGATION, THE PATIENT'S SAMPLE WAS RESULTED CORRECTLY. THE PATIENT'S SAMPLE, BARCODE (B)(6), WAS LOCATED ON PLATE-H068961 AT POSITION E3. THE PATIENT'S SAMPLE YIELDED A VIRAL CT VALUE OF 'INFINITY' MEANING THAT THE VIRUS WAS NOT DETECTED IN THE PATIENT'S SAMPLE. THE WORD 'INFINITY' AS IT PERTAINS TO NEGATIVE RESULTS MEANS NO DETECTION OF THE VIRUS CAN BE FOUND AFTER 43 CYCLES THROUGH PCR AMPLIFICATION. THE FLOATING BLANK WAS LOCATED IN POSITION B6. A FLOATING BLANK IS A WELL ON THE 96-WELL PCR PLATE THAT IS INTENTIONALLY LEFT BLANK (THAT HAS NO SPECIMEN) THAT IS USED TO HELP VERIFY THE CORRECT POSITION OF THE PLATE IN THE PCR RESULT SOFTWARE WHEN THE PLATE IS UNDERGOING REVIEW. IN THIS INSTANCE, THE FLOATING BLANK YIELDED A VIRAL CT VALUE OF 'INFINITY' WHICH IS CONSIDERED ACCEPTABLE. 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. LOT NUMBERS FOR THE POSITIVE CONTROLS WERE 020922RDP-1159 AND 020922RDP-0500. THE LOT NUMBERS FOR THE NEGATIVE CONTROLS USED WERE SDNEG-77016101-312 AND SDNEG-77016101-313. IN CONCLUSION, CURATIVE CANNOT CONFIRM THE PATIENT'S CLAIM OF FALSE NEGATIVE. THE RESULTS OF THE INVESTIGATION SUPPORT THE NEGATIVE RESULT.

    Description of Event or Problem · 0

    SEE ATTACHED MEDWATCH LETTER - MW5108961.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186111 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 30 YR Female