BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1832178 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05381
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE ADVANTAGE SYSTEM USED. (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A RESULT OF 309 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 58 MG/DL ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT HE GAVE HER SOME JUICE AS SHE WAS HAVING HYPOGLYCEMIC SYMPTOMS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM. A PATIENT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 551292

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR LASIX (DAILY)| ZOCOR (DAILY)| HUMALOG (SLIDING SCALE)| ASPIRIN (DAILY)| LANTUS (DAILY)| DIOVAN (DAILY)| SYNTHYROID (DAILY)| TOPROL XL (DAILY)| ZYRTEC (DAILY)| SIMVASTATIN (DAILY)