BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2385738 · Received December 16, 2011

    Report

    Report Number
    2183996-2011-03036
    Event Type
    Injury
    Date Received
    December 16, 2011
    Date of Event
    December 13, 2011
    Report Date
    December 15, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    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

    DIET COUNSELOR REPORTED THE CARTRIDGE OF A DEMO INFUSION DEVICE "EMPTIED BY ITSELF." THE ALLEGED INFUSION DEVICE IS NOT FOR HUMAN USE, AND THIS WAS "EXPLICITLY STATED" BY A COMPANY REPRESENTATIVE BEFORE IT WAS GIVEN TO THE DIET COUNSELOR. DIET COUNSELOR REPORTED THE PATIENT RECEIVED TRAINING ON (B)(6) 2011 AT 11:00 A.M. AFTER THE TRAINING, PATIENT'S BLOOD GLUCOSE LEVEL WAS 57 MG/DL. IN ACCORDANCE WITH THE TRAINING PROCEDURE, PATIENT REMAINED IN STATIONARY TREATMENT AT THE HOSPITAL FOR SUPERVISION. PATIENT STARTED THE DEMO INFUSION DEVICE AT 3:45 P.M., AND HER BLOOD GLUCOSE WAS 260 MG/DL. BLOOD GLUCOSE WAS 300 MG/DL AT 5:00 P.M., AND SHE ADMINISTERED 12 UNITS OF INSULIN VIA SYRINGE. PATIENT HAD SUPPER AND ATE 4 KE. SHE RECEIVED FURTHER INSTRUCTION FROM THE DIET COUNSELOR FROM 5:30-5:45 P.M. BLOOD GLUCOSE WAS APPROXIMATELY 30 MG/DL AT 2:00 A.M. ON (B)(6) 2011. SHE RECEIVED A GLUCOSE INFUSION AT 4:30 A.M., AND BLOOD GLUCOSE WAS APPROXIMATELY 50 MG/DL AT 7:00 A.M. DIET COUNSELOR CHECKED THE INFUSION DEVICE AND NOTICED IT WAS IN THE STOP MODE AND THERE WAS A CARTRIDGE EMPTY (E1) ERROR AT 2:30 A.M. DIET COUNSELOR CONFIRMED THE CARTRIDGE WAS EMPTY. PATIENT COLLAPSED AND WAS UNCONSCIOUS AT 8:20 A.M. AND WAS IMMEDIATELY TRANSFERRED TO THE INTENSIVE CARE UNIT. PATIENT DID NOT HAVE AN INFECTION OR START NEW MEDICATION, AND THE INFUSION DEVICE WAS NOT EXPOSED TO ELECTROMAGNETIC FIELDS OR WATER. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R INSULIN INFUSION PUMP AND RELATED ACCESSORIES| INSULIN| DATE OF THERAPY: PUMP USER SINCE (B)(6) 2011