BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHE ACCUCHEK INFORM METERS

    MDR report key: 1510278 · Received September 28, 2009

    Report

    Report Number
    MW5013023
    Event Type
    Injury
    Date Received
    September 28, 2009
    Date of Event
    September 12, 2009
    Report Date
    September 25, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD FINAL SUMMARY: PT ON PERITONEAL DIALYSIS AND PLAN WAS FOR DISCHARGE BUT THEN, PT HAD SEIZURE. APPARENTLY, MALTOSE IN HIS DIALYSATE WAS INTERFERING WITH HOSPITAL GLUCOMETER AND HE WAS BECOMING HYPOGLYCEMIC THOUGH FSG (FINGER STICK GLUCOSE) REMAINED NORMAL. TREATED WITH DILANTIN AND APPROPRIATE GLYCEMIC CONTROL WITH NO FURTHER SEIZURES. REQUIRED TRANSFER TO HIGHER CARE LEVEL TO STABILIZE GLYCEMIC CONTROL AND LOS EXTENDED BY 7 DAYS. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: TYPE II DM FOR GLYCEMIC CTRL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE ACCUCHEK INFORM METERS GLUCOMETER NBW ROCHE DIAGNOSTICS 2001201 550925
    2 ACCU-CHEK COMFORT CURVE TEST STRIPS NONE LFR

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention