BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1803024 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04880
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 10, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE ADVANTAGE SYSTEM USED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC INSUFFICIENCY AND FRACTURE.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 114 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 250 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALLEGED, AT ANOTHER TIME, OBTAINING A RESULT OF 114 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 299 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. 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 551277

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR VISTARIL| CALCIUM| CENTRUM CARDIO| NEXIUM| LOPID| BENAZEPRIL| ASPIRIN| GLIPIZIDE| BLOOD PRESSURE MONITOR| TRAZADONE| WELLBUTRIN| NEURONTIN| CINNAMON| DIPHENHYDRAMINE| METFORMIN| BACLOFEN| OMEGA 3 FISH OIL| HEART STENT