BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170073 · Received July 13, 2011

    Report

    Report Number
    2183996-2011-02016
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT WAS HOSPITALIZED ON (B)(6) 2011 FOR DIABETIC KETOACIDOSIS. PATIENT CHANGED THE INFUSION SET AND INSULIN CARTRIDGE ON (B)(6) 2011. BLOOD GLUCOSE WAS 358 MG/DL ON (B)(6) 2011 AT 10:58 P.M. HE DELIVERED A CORRECTION BOLUS BUT CONTINUED TO URINATE FREQUENTLY DURING THE NIGHT, AND HE THEN DELIVERED AN ADDITIONAL BOLUS. BLOOD GLUCOSE WAS 558 MG/DL ON (B)(6) 2011 AT 7:30 A.M., 533 MG/DL AT 8:37 A.M., 526 MG/DL AT 9:33 A.M., AND 571 MG/DL AT 10:40 A.M. HE DID NOT EAT FOOD, BUT HE DRANK TEA AND VOMITED. BLOOD GLUCOSE WAS "HI" MG/DL AT 3:10 P.M. AND 3:37 P.M. PATIENT WAS "ALMOST UNCONSCIOUS" AND HIS WIFE CALLED AN AMBULANCE. BLOOD GLUCOSE WAS 716 MG/DL AT THE HOSPITAL, AND PHYSICIAN DISCONNECTED THE INFUSION DEVICE TO EROGATE INSULIN IN VEIN. PATIENT DID NOT CHANGE THE INFUSION HEADSET WHEN HIS BLOOD GLUCOSE WAS ELEVATED. PATIENT DELIVERED A 5 UNIT BOLUS AT 11:00 P.M. ON (B)(6) 2011. ON (B)(6) 2011, HE DELIVERED 5 UNITS AT 1:27 A.M., 12.5 UNITS AT 7:33 A.M., 7 UNITS AT 9:37 A.M., 1 UNIT AT 10:44 A.M., 5.5 UNITS AT 10:46 A.M., AND 11 UNITS AT 3:15 P.M. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R INSULIN INFUSION SET| INSULIN