BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TEST STRIPS

    MDR report key: 2123275 · Received June 14, 2011

    Report

    Report Number
    1823260-2011-03258
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH FIELDS COMPLETED WITH 'NI' WERE SUBMITTED AS SUCH BECAUSE THE INFORMATION WAS NOT REPORTED ON THE VOLUNTARY MEDWATCH RECEIVED BY THE MANUFACTURER. ADDITIONALLY, THE VOLUNTARY MEDWATCH DID NOT PROVIDE ANY DETAILS THAT WOULD ALLOW THE MANUFACTURER TO IDENTIFY THE COMPLAINANT; THEREBY PRECLUDING THE POSSIBILITY OF CONTACTING THE FACILITY FOR FURTHER INFORMATION. DEVICE WAS NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    A VOLUNTARY MEDWATCH REPORT, FORWARDED BY THE F.D.A. TO THE MANUFACTURER, REPORTED THAT A CONTINUOUS AMBULATORY PERITONEAL DIALYSIS PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT COINCIDENT WITH EXTRANEAL THERAPY (A LABELED INTERFERENT FOR MOST ACCU-CHEK TEST STRIPS). THE REPORT STATES THAT THE PATIENT'S BLOOD GLUCOSE WAS MEASURED, ON AN UNSPECIFIED ACCU-CHEK DEVICE, AT 12:56 AM WITH A RESULT OF 411 MG/DL. BASED ON THIS VALUE, PATIENT WAS REPORTEDLY TREATED WITH 22 UNITS OF NOVOLOG. AT AN UNSPECIFIED TIME, THE PATIENT WAS FOUND UNRESPONSIVE IN BED. AT 5:00 AM, PATIENT'S BLOOD GLUCOSE REPORTEDLY MEASURED 160 MG/DL ON THE ACCU-CHEK DEVICE, WHILE A SERUM BLOOD GLUCOSE TEST REPORTED A VALUE OF 50 MG/DL. THE REPORT NOTES THAT PATIENT WAS TREATED WITH D50W AND RECOVERED WITHOUT SEQUELAE. A DIABETES EDUCATOR, NURSE EDUCATOR, AND CLINICAL PHARMACIST WERE SUBSEQUENTLY ASKED TO REVIEW THE EVENT, AT WHICH TIME THEY DISCOVERED THAT THE TEST STRIPS' USE IS CONTRAINDICATED FOR PATIENTS ON EXTRANEAL THERAPY. THE ACCU-CHEK SYSTEM WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NOVOLOG| EXTRANEAL