BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002277 · Received February 22, 2008

    Report

    Report Number
    1823260-2008-01782
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER TOOK 35 UNITS OF LANTUS AND 2 UNITS OF HUMALOG, ATE BREAKFAST, AND WAS UNRESPONSIVE ABOUT 2-4 HOURS LATER. REPORTER ALLEGED THE FAMILY CALLED 911 AND THEN OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 279 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 50 MG/DL AND ANOTHER RESULT LESS THAN 50 MG/DL ON THE EMT'S METER WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER STATED THE EMTS TREATED HER WITH A GLUCOSE IV AND TOOK HER TO THE HOSPITAL WHERE SHE STAYED FOR THE NIGHT AND WAS GIVEN FOOD AND INSULIN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. REPORTER STATED THAT THE STRIPS WERE DISCARDED, AND SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R LANTUS - NO LONGER ON - 35 UNITS DAILY| HUMALOG - SEVERAL YEARS - SLIDING SCALE| LANTUS - SEVERAL YEARS - 25 UNITS DAILY