BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 4151270 · Received October 8, 2014

    Report

    Report Number
    1823260-2014-07708
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6) WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY CASSETTE WAS RETURNED. NOTE: DURING INVESTIGATION OF RETURNED METER, THE RESULT OF 310 MG/DL WAS NOT FOUND.

    Description of Event or Problem · 1

    REPORTER STATED CUSTOMER TESTED ON THE MOBILE SYSTEM AT APPROXIMATELY 7:00 AM AND RECEIVED A RESULT OF 310 MG/DL. BASED ON THIS RESULT THE CUSTOMER INJECTED 22 UNITS OF HUMALOG. "SHORTLY AFTERWARDS" THE CUSTOMER FELT UNWELL, DIZZY, AND HAD TREMORS. HE THEN COLLAPSED AND WAS UNRESPONSIVE. HIS WIFE CALLED THE FAMILY PHYSICIAN. WHEN HE ARRIVED HE INJECTED THE CUSTOMER WITH GLUCOSE. THE CUSTOMER WAS THEN RESPONSIVE. THE AMBULANCE PERSONNEL ARRIVED AND OBTAINED A RESULT, HOWEVER, THAT VALUE IS NOT AVAILABLE. THE CUSTOMER WAS TREATED WITH A GLUCOSE DRIP AND WAS TRANSPORTED TO HOSPITAL. CUSTOMER ARRIVED TO THE HOSPITAL AT APPROXIMATELY 8:00 AM AND CUSTOMER WAS DISCHARGED THE SAME DAY AT APPROXIMATELY 11:00 AM. THE CUSTOMER HAS SINCE RECOVERED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633018 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278306

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR Hospitalization| R HUMALOG