BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND TEST STRIPS

    MDR report key: 10958169 · Received December 7, 2020

    Report

    Report Number
    1823260-2020-03108
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 29, 2019
    Report Date
    January 4, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K952875
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D9 AND H3 UPDATED. THE CUSTOMER'S METER WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION FOUND THE DEVICE TO BE CONTAMINATED WITH HUMAN MATERIAL (BLOOD). THE INVESTIGATOR ATTEMPTED TO CLEAN THE DEVICE, BUT FOUND THAT THE DEVICE IS BROKEN AND NO MEASUREMENTS ARE POSSIBLE. THE CUSTOMER'S GLUCOSE STRIPS LOT 349029-01 HAVE EXPIRED IN MAY 2020. RETENTION SAMPLES GLUCOSE LOT 349029-01 AND REFERENCE LOT GLUCOSE 481926-80 WERE MEASURED WITH CONTROLS GKL 60 LOT 346092-99/GKL 180 LOT 346093-99 AND 2 EDTA BLOOD ON REFERENCE DEVICES COMPARED TO LABORATORY METHOD. RESULTS: ALL RESULTS WERE WITHIN THE CONTROL RANGE. NO SIGNIFICANT DIFFERENCES TO THE LABORATORY METHOD. THE CUSTOMER'S DEVICE IS BROKEN. THERE WERE NO ABNORMALITIES IN THE TEST STRIPS. BASED ON THE MEASUREMENTS, NO PRODUCT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE ACCUTREND GLUCOSE TEST STRIP LOT 34902901 WHICH WAS USED FOR THE ALLEGED MEASUREMENTS ON THE DATE OF THE EVENT IN 2019, HAD ALREADY EXPIRED AT THE TIME THE COMPLAINT WAS RECEIVED. THEREFORE, THE TEST STRIPS WERE NOT REQUESTED FOR RETURN. THE CUSTOMER'S METER WAS REQUESTED FOR RETURN. PRODUCT LABELING STATES: "THIS SYSTEM HAS NOT BEEN PROVEN FOR USE WITH NEONATES." THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE RESULTS FROM AN ACCUTREND PLUS METER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS APPROXIMATELY 180 MG/DL. THE EXACT VALUE WAS NOT PROVIDED. THE REPEATED RESULT WAS 83 MG/DL. THE REPEATED RESULT WAS TAKEN WITHIN 15 MINUTES OF THE INITIAL RESULT. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT. BOTH RESULTS WERE TAKEN AT THE PATIENT'S PEDIATRICIAN'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423257 ACCUTREND TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA 34902901

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA