BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SENSOR TEST STRIPS

    MDR report key: 2076667 · Received May 4, 2011

    Report

    Report Number
    1823260-2011-02387
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    January 1, 2005
    Report Date
    May 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL FIELDS SHOWING "NI" WERE COMPLETED AS SUCH BECAUSE INFORMATION WAS NOT AVAILABLE FROM THE JOURNAL ARTICLE. NO INFORMATION WAS RECEIVED FROM THE ARTICLES' AUTHORS. JOURNAL ARTICLE: J. KADOUA, F. COENENB, P. VINCENTA, A. FOROUZANFARDA AND I.M. COLINC, SURESTIMATION DE LA GLYCÉMIE CAPILLAIRE CHEZ DES PATIENTS DIABÉTIQUES, INSUFFISANTS RÉNAUX ET TRAITÉS PAR DIALYSE PÉRITONÉALE : UN PIÈGE À ÉVITER. JOURNAL EUROPÉEN DES URGENCES 23(4)(2010), PP. 89-92. THE EVENT OCCURRED IN (B)(4). DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE REPORTS THAT A PERITONEAL DIALYSIS PATIENT, USING THE DIALYSATE EXTRANEAL (A LABELED INTERFERENT FOR MOST ACCU-CHEK TEST STRIPS), WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY ROOM DUE TO CONFUSION AND RESPIRATORY DISTRESS. EMERGENCY MEDICAL SERVICES HAD TESTED PATIENT'S BLOOD GLUCOSE, ON AN ACCU-CHEK SENSOR SYSTEM, WITH A RESULT OF 146 MG/DL. UPON ADMISSION, PATIENT WAS DIAGNOSED WITH ACUTE PULMONARY EDEMA; HIS CONDITION QUICKLY IMPROVED AFTER TREATMENT WITH 320 MG INTRAVENOUS FUROSEMIDE. THE REPORT NOTES THAT PATIENT'S BLOOD GLUCOSE WAS RETESTED IN THE EMERGENCY DEPARTMENT, ON A DEVICE IDENTICAL TO THAT OF THE EMS' [ACCU-CHEK SENSOR], WITH A RESULT OF 116 MG/DL. DUE TO PREVIOUS EXPERIENCE WITH THIS POSSIBLE DRUG/DEVICE INTERACTION (ICODEXTRIN/GDH-PQQ TYPE GLUCOSE STRIPS), THE MEDICAL STAFF IMMEDIATELY MEASURED PATIENT'S BLOOD GLUCOSE IN THE LAB WHICH RETURNED A RESULT OF LESS THAN 30 MG/DL (EXACT VALUE WAS NOT REPORTED). PATIENT WAS TREATED WITH 5 G INTRAVENOUS GLUCOSE, RELAYED IN A SOLUTION OF 10% GLUCOSE. REPORT NOTES THAT PATIENT QUICKLY RECOVERED FROM HYPOGLYCEMIA AND WAS TRANSFERRED TO THE NEPHROLOGY WARD. THE JOURNAL ARTICLE DID NOT INDICATE WHEN PATIENT WAS LAST DIALYZED PRIOR TO ADMISSION. NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR Required Intervention EXTRANEAL| INSULIN (TYPE UNKNOWN)