BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 6126063 · Received November 23, 2016

    Report

    Report Number
    3011393376-2016-07535
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    November 22, 2016
    Report Date
    April 3, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    CALLER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN ACTIVE METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: 196 MG/DL (METER) AND 102 MG/DL (LAB). THE PATIENT'S DOCTOR DOUBLED THE AMOUNT OF MEDICATION BASED ON THE METER RESULTS. IT WAS REPORTED THAT "THE PATIENT WAS TAKING TABLETS TWO TIMES IN A DAY, AND DUE TO THE METER'S INCORRECT RESULTS THE DOCTOR INCREASED THE DOSAGE DOUBLE OF THAT, AND AS A RESULT THE PATIENT WAS ADMITTED INTO THE ICU." THE BLOOD GLUCOSE RESULTS AND TYPE OF TREATMENT PROVIDED BY THE HOSPITAL WAS NOT PROVIDED. IT IS UNKNOWN HOW LONG THE PATIENT WAS HOSPITALIZED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775553 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 24647732

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization