BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME TEST STRIPS

    MDR report key: 14208900 · Received April 26, 2022

    Report

    Report Number
    1832816-2022-00004
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 19, 2022
    Manufacturer
    ARKRAY FACTORY USA, INC.
    Product Code
    CGA
    UDI-DI
    00605388022943
    PMA / PMN Number
    K091102/001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED TWO BOTTLES OF SPECIFIED STRIPS. BOTTLE 1 WAS RETURNED WITH 46 STRIPS; SIX OF THESE STRIPS WERE TESTED, AND FAILED TESTING READING LO ON ALL THREE BLOOD LEVELS CONFIRMING THE COMPLAINT. BOTTLE 2 WAS RETURNED WITH 50 STRIPS AND PASSED TESTING WITH NO FAILURES DETECTED. TWO BOTTLES OF RETAIN STRIPS WERE TESTED AS WELL. BOTTLE 1 OF RETAINS FAILED TESTING READING LO ON THE 150MG/DL AND 300MG/DL BLOOD LEVELS. BOTTLE 2 OF RETAINS PASSED TESTING WITH NO FAILURES DETECTED. DESICCANT TESTING WAS PERFORMED ON FAILED STRIP BOTTLES AND PASSED TESTING INDICATING MOISTURE INTRUSION IS NOT THE CAUSE OF THE OBSERVED STRIP FAILURE, INDICATING THAT USER ERROR IS MOST LIKELY NOT A FACTOR IN THE CONFIRMED FAILURE. COMPLAINT PRODUCTS WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ISSUES OF LOW BLOOD READINGS. COMPLAINT WAS REVIEWED FOR INVESTIGATION AND REPORTABILITY ON (B)(6) 2022. COMPLAINT WAS MARKED FOR INVESTIGATION AND DETERMINED NOT REPORTABLE PER ARKRAY'S PER INTERNAL PROCEDURES. ON (B)(6) 2022, RETURNED STRIPS FAILED TESTING BY GENERATING LOW RESULTS OUT OF SPECIFICATION. THE STRIPS GAVE LOW READINGS, MAKING THIS COMPLAINT REPORTABLE TO THE MANUFACTURER AS A MALFUNCTION. (B)(6) 2022 MARKS THE AWARE DATE FOR MDR FILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365881 RELION PRIME TEST STRIPS GLUCOSE OXIDASE, GLUCOSE CGA ARKRAY FACTORY USA, INC. 700100 122921B 00605388022943

    Patients

    Seq Age Sex Outcome Treatment
    1 Male