BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® INFORM

    MDR report key: 1871213 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06157
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE INFORM SYSTEM (B)(4). (B)(4).

    Description of Event or Problem · 1

    CALLER STATES THAT AN UNCONSCIOUS PATIENT ARRIVED IN THE EMERGENCY ROOM (ER). PARAMEDICS HAD OBTAINED A HIGH BLOOD GLUCOSE RESULT PRIOR TO THE PATIENT ARRIVING IN THE ER (RESULT NOT REPORTED). PATIENT WAS UNDIAGNOSED AT TIME OF THE ARRIVAL IN THE ER. A NURSE IN THE ER USED BOTH METERS ON THE PATIENT AND RECEIVED AN ERROR-83 ON THE INFORM METER. CALLER REPORTED THAT ALTHOUGH THE PARAMEDICS HAD OBTAINED A HIGH BLOOD GLUCOSE VALUE, NURSES TREATED THE PATIENT WITH A D50 IV BASED UPON THE ERROR MESSAGE INDICATING THAT THE GLUCOSE SAMPLE WAS TOO LOW TO DETECT. CALLER STATES THAT THE NURSE'S RATIONALE WAS TO TREAT THE PATIENT WITH D50 BASED ON THE ERROR MESSAGE INDICATION THAT THE GLUCOSE WAS TOO LOW TO DETECT AND THE PATIENT'S PHYSIOLOGICAL CONDITION AT THE TIME IN ATTEMPT TO STABILIZE THE PATIENT. THE PATIENT'S GLUCOSE RESULT FROM THE LAB CAME BACK AS 960 MG/DL. IT WAS NOT CLEAR AS TO WHETHER THIS LAB WAS TAKEN BEFORE OR AFTER THE D50 WAS STARTED. THE PATIENT'S INITIAL HEMATOCRIT PRIOR TO ANY TREATMENT WAS 58.2%. THIS IS OUTSIDE OF THE RANGE OF 20-55% FOR GLUCOSE MEASUREMENTS GREATER THAN 200 MG/DL. AFTER THE LAB VALUE WAS REPORTED, THE D50 IV WAS DISCONTINUED AND THE PATIENT RECEIVED AN INSULIN IV AND WAS TRANSPORTED TO THE ICU. IN THE ICU, THEY RECEIVED A VALUE OF "HI" (GREATER THAN 600 MG/DL) ON THE PATIENT. THERE WAS NO TIMEFRAME REPORTED BETWEEN THE LAB VALUE AND THE RESULT OF HI. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® INFORM BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization INSULIN ASPART| HEPARIN| D50 IV| ONDANSATRON| POTASSIUM CHLORIDE| SODIUM CHLORIDE| REGULAR INSULIN - TYPE UNKNOWN