BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1933468 · Received December 20, 2010

    Report

    Report Number
    1823260-2010-07564
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 13, 2010
    Report Date
    February 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 182 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 93 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALSO ALLEGED OBTAINING A RESULT OF 162 MG/DL ON THE SAME ADVANTAGE SYSTEM THE NEXT DAY COMPARED BACK TO BACK WITH A RESULT OF 82 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT HE HAD TAKEN MEDICATION LESS THAN 15 MINUTES BEFORE RUNNING THE TEST ON HIS DEVICE, BUT HE DID NOT SPECIFY WHICH MEDICATION HE TOOK. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 NA 551360

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR METFORMIN| BUPROPION (TWICE DAILY)| LEVOTHYROXINE (DAILY)| GLIPIZIDE| JANUVIA| LISINOPRIL (DAILY)