BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN TEST

    MDR report key: 15775774 · Received November 10, 2022

    Report

    Report Number
    3009238284-2022-00015
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 10, 2022
    Report Date
    December 2, 2022
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1 TEST CASSETTE IN THE KIT DID NOT HAVE THE CONTROL AND TEST LINE MARKINGS, REQUIRED TO READ THE OUTPUT RESULT. IN ABSENCE OF THE LABELS, CUSTOMER USED ANOTHER TEST CASSETTE FROM THE KIT TESTING. THE CAUSE OF THE EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HEALGEN HAS COMPLETED THE INVESTIGATION. RETAINED SAMPLES FROM LOT 2203332 WERE CHECKED AND ALL CASSETTES WERE FOUND IN A GOOD CONDITION. THE MANUFACTURING PROCESS WAS ALSO REVIEWED. THE APPROPRIATE STEPS WERE FOUND TO BE FOLLOWED PER THE 2-STEP STANDARD OPERATING PROCEDURE (SOP). BASED ON THE INVESTIGATION, IF EITHER OF THE "T" OR "C" MARKINGS ARE MISSING ON A CASSETTE, THAT CASSETTE SHOULD BE PICKED OUT DURING STEP 2 OF THE CASSETTE ASSEMBLY PROCESS. THE DEFECTIVE PRODUCT SHOULD HAVE BEEN PICKED OUT DURING THE ASSEMBLY PROCESS. PER THE SUPPLIER, A LACK OF INK DURING PRODUCTION COULD HAVE CAUSED MISSING "T" AND "C" MARKINGS ON THE CASSETTE AND MISSING MARKINGS IN A TEST KIT IS MOST LIKELY DUE TO OPERATOR ERROR. TRAINING WILL BE ENHANCED FOR RELATIVE OPERATORS AND THE IMPORTANCE OF STRICTLY COMPLYING WITH THE SOP DURING THE PRODUCTION PROCESS WILL BE ENFORCED. PHYSICAL DEFECTS WILL CONTINUE TO BE MONITORED BY THE SUPPLIER. THE ISSUE WAS NOT REPRODUCED AND IS NOT CONSIDERED TO BE SYSTEMIC. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    AS HOLDERS OF THE EMERGENCY USE AUTHORIZATION, SIEMENS HEALTHCARE DIAGNOSTICS IS SUBMITTING THIS REPORT ON BEHALF OF THE MANUFACTURER HEALGEN SCIENTIFIC. THE CUSTOMER REPORTED THAT PRINTED TEXT FOR C AND T LINES, WERE MISSING ON CASSETTE OF ONE OF THE TESTS IN THE KIT. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284606 CLINITEST RAPID COVID-19 ANTIGEN TEST CLINITEST RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC 2203332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown