BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN TEST

    MDR report key: 16134562 · Received January 10, 2023

    Report

    Report Number
    3009238284-2023-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 25, 2022
    Report Date
    February 9, 2023
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HEALGEN HAS COMPLETED THE INVESTIGATION. AFTER REVIEWING THE RELEVANT MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT NUMBER 2204622EUA, NO IRREGULARITIES WERE FOUND BY THE SUPPLIER OF TUBES. TESTS RETAINED FROM LOT NUMBER 2204622EUA WERE TESTED - WITH BUFFER SOLUTION ONLY, WITH NASAL EXTRACT- AND WITH NASAL MUCUS. ALL DEVICES PERFORMED AS EXPECTED WHEN TESTED. BASED ON INVESTIGATIONS, MANUFACTURER WAS UNABLE TO REPLICATE THE CUSTOMER'S COMPLAINT. NO IRREGULARITIES OR DEVIATIONS WERE OBSERVED IN THE MANUFACTURING DOCUMENTATION FOR THE COMPLAINT RELATED LOT. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    EVENT CAME TO THE KNOWLEDGE OF SIEMENS HEALTHINEERS ON 01-04-2023 FROM HEALGEN WHO LEARNT THROUGH FDA MEDWATCH PROGRAM EMAIL ON 01-03-2023. CUSTOMER DID NOT CONTACT SIEMENS OR THE MANUFACTURER - HEALGEN. THE CUSTOMER FAILED TO FOLLOW THE INSTRUCTIONS PROVIDED WITH THE DEVICE. QUICK REFERENCE INSTRUCTIONS ALSO MENTIONS TO MAKE SURE THERE IS A TIGHT FIT OF FILTER TIP TO THE TUBE. THIS WOULD HAVE AVOIDED FILTER TIP TO POP OUT. FOR ANY QUESTIONS OR CONCERNS, CUSTOMER CARE HOTLINE PHONE NUMBER AND EMAIL ARE PROVIDED ON QUICK REFERENCE INSTRUCTIONS PROVIDED WITH EACH TEST KIT. PER THE SAFETY DATA SHEET, "NOT CLASSIFIED AS DANGEROUS ACCORDING TO DIRECTIVE (EC) NO. 1272/2008.". ALTHOUGH THE BUFFER SOLUTION IS NOT INTENDED TO COME IN CONTACT WITH THE PATIENT OR USER, HOWEVER, SPEWING WILL NOT RESULT IN ANY ADVERSE EVENT. 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 UPON SQUEEZING THE SAMPLE TUBE TO APPLY SAMPLE TO CLINITEST COVID TEST STRIP, FILTER POPS OFF THE TUBE DUE TO CLOGED FILTER, SPEWING OUT SAMPLE WITH REAGENT. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723252 CLINITEST RAPID COVID-19 ANTIGEN TEST CLINITEST RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC 2204622EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown