BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK STRIPS USING GDH-PQQ TECHNOLOGY

    MDR report key: 2081832 · Received May 5, 2011

    Report

    Report Number
    MW5020513
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ROCHE
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS ON CAPD USING EXTRANEAL DIALYSATE SOLUTION. PT ADMITTED TO HOSPITAL AND HOSPITAL USES ACCU-CHEKS FOR BEDSIDE BLOOD GLUCOSE MONITORING. PT FOUND IN UNRESPONSIVE IN BED. ACCU-CHEK = 160 AND FASTING SERUM BLOOD GLUCOSE = 50 AT 0500. EARLIER IN MORNING AT 0056, PT RECEIVED NOVOLOG 22 UNITS FOR AN ACCU-CHEK READING OF 411. DIABETIC EDUCATOR, NURSE EDUCATOR, AND CLINICAL PHARMACIST WAS CALLED TO REVIEW PT RELATED EVENTS. DISCOVERED THAT EXTRANEAL DIALYSATE SOLUTION IS ON THE LIST OF MEDICATIONS THAT INTERACT WITH THE ACCU-CHEK TEST STRIPS UTILIZING GLUCOSE DEHYDROGENASE PYRROLOQUINOLINEQUINONE (GDH-PQQ) TECHNOLOGY. GDH-PQQ DOES NOT DISTINGUISH BETWEEN GLUCOSE AND OTHER SUGARS SUCH AS ICODEXTRAN FOUND IN EXTRANEAL SOLUTIONS. INFO REGARDING THIS DRUG-DEVICE INTERACTION OBTAINED FROM THE (B)(6) 2008 NURSE ADVISE-ERR. PT RECEIVED D50W TO TREAT SYMPTOMS OF HYPOGLYCEMIA AND RECOVERED WITHOUT SEQUELAE. PT USES ONE-TOUCH METER AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK STRIPS USING GDH-PQQ TECHNOLOGY ACCU-CHEK TEST STRIPS NBW ROCHE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention ROUTE: SC| DOSE OR AMOUNT: NOVOLOG 22 UNITS, FREQUENCY: ONCE