BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND CHOLESTEROL

    MDR report key: 8846998 · Received July 31, 2019

    Report

    Report Number
    1823260-2019-02791
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 22, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHH
    PMA / PMN Number
    K051376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S METER AND STRIPS WERE RETURNED FOR INVESTIGATION. THE RETURNED PRODUCT WAS MEASURED IN COMPARISON TO A REFERENCE METER AND RETENTION LOT STRIPS. CUSTOMER SAMPLES CHOLESTEROL LOT 349024-04 AND RETENTION SAMPLES CHOLESTEROL LOT 349024-04 WERE MEASURED WITH CONTROLS LEVEL LOW /HIGH LOT 403614-01 ON CUSTOMER ACCUTREND PLUS DEVICES AND REFERENCE DEVICES. LOW CONTROL MEASUREMENTS: TESTING RESULTS (QC RANGE: 163 - 207 MG/DL): CUSTOMER METER: QC 1: 195.0 MG/DL, QC 2: 188.1 MG/DL, QC 3: 193.9 MG/DL. REFERENCE METER: QC 1: 193.0 MG/DL, QC 2: 181.0 MG/DL, QC 3: 188.0 MG/DL HIGH CONTROL MEASUREMENTS: TESTING RESULTS (QC RANGE: 224 - 284 MG/DL): CUSTOMER METER: QC 1: 246.1 MG/DL, QC 2: 257.0 MG/DL, QC 3: 248.8 MG/DL. REFERENCE METER: QC 1: 251.0 MG/DL, QC 2: 260.0 MG/DL, QC 3: 268.0 MG/DL. ALL RESULTS WERE WITHIN THE CONTROL RANGE. THE RESULTS OF ALL MEASUREMENTS FULFILLED THE REQUIREMENTS. NO SIGNIFICANT DIFFERENCES COULD BE IDENTIFIED BETWEEN THE CUSTOMER SAMPLES /CUSTOMER METER AND REFERENCE DEVICES/ RETENTION SAMPLES.

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL RESULTS WERE ACCEPTABLE. THE CUSTOMER¿S STRIPS WERE REQUESTED FOR RETURN. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF A QUESTIONABLE CHOLESTEROL RESULT FROM AN ACCUTREND PLUS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNSPECIFIED LABORATORY METHOD. THE INITIAL CHOLESTEROL RESULT FROM THE METER WAS LOW. A "LOW" ALARM MEANS THE RESULT WAS BELOW THE MEASUREMENT RANGE. THE MEASUREMENT RANGE FOR CHOLESTEROL IS 3.88 - 7.76 MMOL/L. THE LABORATORY RESULT WAS 7 MMOL/L. THE RESULT IN QUESTION WAS REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640695 ACCUTREND CHOLESTEROL CHOLESTEROL (TOTAL) TEST SYSTEM CHH ROCHE DIAGNOSTICS NA 34902404

    Patients

    Seq Age Sex Outcome Treatment
    1