BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRON V-100 INSULIN INFUSION PUMP

    MDR report key: 157556 · Received March 17, 1998

    Report

    Report Number
    2183996-1998-00010
    Event Type
    Malfunction
    Date Received
    March 17, 1998
    Date of Event
    February 5, 1998
    Report Date
    March 5, 1998
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULTS OF THE EXAMINATION AND ON CO'S KNOWLEDGE CO CAN MAKE THE FOLLOWING STATEMENT: THE INSULIN PUMP IS FULLY FUNCTIONING. CO CANNOT FIND ANY DEFECT IN THE PUMP WHICH COULD HAVE BEEN THE REASON FOR THE NON GIVEN ALARM FOR THE EMPTY CARTRIDGE. WHAT COULD HAVE HAPPENED IS THAT THE PT HAD INITIALIZED THE FUNCTION RESETTING FOR A NEW CARTRIDGE" WITH A NONE 100% FILLED CARTRIDGE OR THAT THE FUNCTION. RESTTING FOR A NEW CARTRIDGE" WAS MADE A SECOND TIME WITH A PARTIALLY EMPTY CARTRIDGE. CO RECOMMEND TO MEASURE THE BLOOD SUGAR 4-5 TIMES A DAY TO REDUCE ANY RISKS OF HYPO- OR HYPERGLYCAEMIA. THE H-TRON V100 WITH A LIFETIME OF 24 MONTHS WILL BE KEPT AT DISETRONIC MEDICAL SYSTEMS AG. BURGDORF ACCORDING TO THE REPAIR/WARRANTY MANGEMENT FOR INSULIN PUMPS 27TH FEBRUARY 1996.

    Description of Event or Problem · 1

    THE PT STATED THAT THE CARTRIDGE WAS EMPTY BUT THAT THE END OF CARTRIDGE ALARM NEVER SOUNDED. HER BLOOD GLUCOSE LEVEL ROSE TO 700 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRON V-100 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS H-TRON V-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other INSULIN, SUBCUTANEOUS INSULIN INFUSION SET.