BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 4131832 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07491
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 7, 2014
    Report Date
    March 19, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S WIFE REPORTED PATIENT RECEIVED A READING OF HI. WIFE STATED HE BEGAN VOMITING AT 2:30 AM AND HAS NOT BEEN FEELING GOOD. WIFE REPORTED DRIVING THE PATIENT TO THE HOSPITAL WHEN HE COULD NOT LOWER HIS BLOOD GLUCOSE LEVEL AND HE WAS ADMITTED. WIFE STATED THE METER REGISTERED HI PRIOR TO GOING TO THE HOSPITAL. WIFE REPORTED WHEN THEY TESTED HIM AT THE HOSPITAL ABOUT 30 MINUTES AFTER THE HOME TEST, THE RESULT WAS ABOVE 600MG/DL; EXACT READING WAS NOT KNOWN. WIFE ALLEGES THE PUMP IS NOT DELIVERING INSULIN PROPERLY. WIFE STATED PATIENT WAS TAKEN OFF OF THE PUMP AND WAS TREATED WITH AN INSULIN DRIP AND A DRIP OF FLUIDS FOR DEHYDRATION. ON CALL BACK PATIENT SWITCHED TO BACKUP PUMP. HOSPITAL DISCARDED THE INFUSION SET AND CARTRIDGE. REQUESTED RETURN OF THE ALLEGED PUMP AND METER; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612491 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR Hospitalization| R VITAMIN D TWO PILLS DAILY| NOVOLOG U100 DOSAGE NOT PROVID| LISINOPRIL 1/2 TABLET DAILY DO