BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3170708 · Received June 14, 2013

    Report

    Report Number
    1823260-2013-03604
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 19, 2013
    Report Date
    July 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER STATED EARLIER, ON THE MORNING OF THE EVENT, TIME UNKNOWN, A SMBG VALUE WAS 384 MG/DL. AT 10:30 A LABORATORY GLUCOSE VALUE WAS DRAWN ON THE PATIENT; THE RESULT WAS 36 MG/DL. THE FLOOR STAFF DID NOT TAKE NOTE OF THIS RESULT. AT 11:33 A SMBG VALUE WAS 274 MG/DL. BASED UPON THE PREVIOUS HIGH SMBG VALUE THE FLOOR STAFF DID NOT QUESTION THIS VALUE. RATHER, BASED ON THIS VALUE THE FLOOR STAFF ADMINISTERED 3 UNITS OF HUMALOG. AT 12:05 A SMBG VALUE ON THE SAME METER WAS 17 MG/DL (ALL SMBG VALUES EXCEPT THE 109 MG/DL VALUE BELOW WERE FROM THE SAME METER). AN IMMEDIATE RETEST VALUE AT 12:07 WAS 26 MG/DL. AT THIS TIME THE FLOOR STAFF RETRIEVED THE PRIOR LABORATORY RESULTS WITH THE EARLIER RESULT OF 36 MG/DL. THE PATIENT WAS ASYMPTOMATIC. SHE WAS TREATED WITH 50ML D50. AT 12:55 WHILE ON THE REPORTING CALL, A SMBG VALUE WITH ANOTHER METER WAS 109 MG/DL. THE PATIENT REMAINS IN STABLE CONDITION. SHE DID NOT SHOW ANY EFFECTS FROM EITHER THE LOW OR HIGH GLUCOSE VALUES THROUGHOUT THE EVENTS. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271060 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551963

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR Required Intervention AMLODIPINE| HYDROMORPHONE| ALBUTEROL IPRATROPIUM| DOCUSATE| WARFARIN| LABETALOL| PANTOPRAZOLE| POTASSIUM CHLORIDE| CALCIUM CARBONATE| CHOLECALCIFEROL| CLONAZEPAM| DIYALPROEX SODIUM| FAMOTIDINE| METOCLOPRAMIDE| METRONIDAZOLE| MIRTAZAPINE| SODIUM CHLORIDE| THIAMINE| ACETAMINOPHEN