BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMEME SARS-COV-2 REAL-TIME RT-PCR TEST

    MDR report key: 12628065 · Received October 13, 2021

    Report

    Report Number
    3014117298-2021-00002
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 12, 2021
    Manufacturer
    BIOMEME, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT 30 OUT OF 93 SAMPLES PRODUCED INCONCLUSIVE RESULTS AND THE IPC FAILED TO AMPLIFY. THEN, THEY RE-RAN THE INCONCLUSIVE SAMPLES AND OF THOSE 30 SAMPLES, 10 WERE INCONCLUSIVE A SECOND TIME. CUSTOMER SERVICE FOLLOWED UP WITH THE INITIAL REPORTER WHO EXPLAINED THAT IN OTHER PACKAGES OF THE SAME LOT (20210723B-A) OF GO-PLATES, THE LYOPHILIZED ASSAY IN SOME WELLS OF THE PCR RXN LOOKED AS THOUGH THEY HAD BEEN REHYDRATED PRIOR TO USE, AND THEY REMOVED THESE WELLS AND USED THE REMAINING WELLS FOR TESTING. THE CUSTOMER DID NOT SPECIFY WHAT QUANTITY OF PACKAGES FROM THAT LOT OF GO-PLATES WAS AFFECTED, AND WAS UNABLE TO PROVIDE PICTURES OR ADDITIONAL INFORMATION WHEN ASKED. REHYDRATION OF THE LYOPHILIZED PCR ASSAY WILL CAUSE THE COMPONENTS OF THE ASSAY TO DEGRADE, AND BE UNUSABLE FOR TESTING. COMMON CAUSES FOR REHYDRATION OF THE ASSAY ARE DUE TO STORAGE OUTSIDE OF THE RECOMMENDED TEMPERATURE RANGE (15C-30C), EXPOSING THE PACKAGE TO HUMIDITY, IMPROPER SEALING OF THE PACKAGE, USE AFTER THE RECOMMENDED OPENED PACKAGE SHELF-LIFE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THEY HAD 30 OUT OF 93 PATIENT SAMPLES FROM ONE PACKAGE OF GO-PLATES (PCR ASSAY) WHERE THE IPC FAILED TO AMPLIFY, WHICH IS AN INCONCLUSIVE RESULT. LATER, USING THE SAME IPC TEMPLATE AS BEFORE, 10 OUT OF 30 SAMPLES AS INCONCLUSIVE. ROUGHLY 33% INCONCLUSIVE RATE WAS SUSPECTED TO BE DUE TO PRODUCT FAILURE AND INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522768 BIOMEME SARS-COV-2 REAL-TIME RT-PCR TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR BIOMEME, INC. 20210723B-A

    Patients

    Seq Age Sex Outcome Treatment
    1