BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND CHOLESTEROL

    MDR report key: 7544153 · Received May 25, 2018

    Report

    Report Number
    1823260-2018-01594
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 31, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHH
    PMA / PMN Number
    K051376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S ACCUTREND PLUS METER WAS RETURNED AND THERE WERE NO ABNORMALITIES OBSERVED. REFERENCE TEST STRIPS OF ACCUTREND CHOLESTEROL LOT NUMBER 238011-00 AND CONTROL SOLUTIONS WERE TESTED ON THE RECEIVED CUSTOMER METER AND ON A REFERENCE METER. LOW CONTROL (RANGE 152-194 MG/DL) CUSTOMER INSTRUMENT: 166 MG/DL, 168 MG/DL, AND 176 MG/DL. REFERENCE INSTRUMENT: 182 MG/DL, 179 MG/DL, AND 170 MG/DL. HIGH CONTROL (RANGE 212-270 MG/DL) CUSTOMER INSTRUMENT: 235 MG/DL, 244 MG/DL, AND 245 MG/DL. REFERENCE INSTRUMENT: 245 MG/DL, 256 MG/DL, AND 249 MG/DL. ALL MEASUREMENTS ON THE CUSTOMER METER AND ON THE REFERENCE METER WERE WITHIN THE CONTROL RANGES. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). DEVICE REQUESTED FOR INVESTIGATION BUT WAS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CHOLESTEROL RESULTS FROM ACCUTREND PLUS METER SERIAL (B)(4). THE DATE OF EVENT IS AN APPROXIMATION. THE CUSTOMER PROVIDED CHOLESTEROL RESULTS OF "LO" (< 150 MG/DL), 250 MG/DL, AND 165 MG/DL. DIFFERENT FINGERS WERE USED FOR EACH MEASUREMENT. IT WAS NOT KNOWN WHEN THE "LO" RESULT WAS OBTAINED, BUT IT WAS PROVIDED THAT THE 250 MG/DL AND THE 165 MG/DL RESULTS WERE OBTAINED 15 MINUTES APART. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE RELEASED TO THE PATIENT OR THE PATIENT'S DOCTOR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. IT WAS PROVIDED THAT THE CUSTOMER DID NOT APPLY ENOUGH BLOOD TO COVER THE ENTIRE TEST AREA. THE CUSTOMER'S CURRENT CONDITION WAS PROVIDED AS WELL. THE CUSTOMER'S METER AND STRIPS WERE REQUESTED FOR INVESTIGATION. THE CUSTOMER'S STRIPS WERE NO LONGER AVAILABLE. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386438 ACCUTREND CHOLESTEROL CHOLESTEROL (TOTAL) TEST SYSTEM CHH ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR