BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1911753 · Received November 22, 2010

    Report

    Report Number
    2531779-2010-02408
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): THERE WAS NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM THE TIME OF THE REPORTED HOSPITALIZATION DUE TO CONTINUED USE. THE TOTAL DAILY DOSE (TDD) WAS FOUND TO BE INCONSISTENT DUE TO TIME AND DATE RESET. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS. UNRELATED TO THE COMPLAINT, THE INTERNAL BATTERY WAS FOUND TO BE LEAKING. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE EXPERIENCED BLOOD GLUCOSE OF 31 MG/DL THAT REQUIRED INTRAVENOUS DEXTROSE ADMINISTRATION BY A PARAMEDIC. HER BLOOD GLUCOSE SHORTLY RESOLVED TO 130 MG/DL WITHOUT THE NEED FOR FURTHER TREATMENT. THE PT REPORTED THAT SHE PERFORMED A ROUTINE INFUSION SET AND CARTRIDGE CHANGE AT 5:30 PM ON (B)(6) 2010. SHE DELIVERED A MANUALLY CALCULATED 5 UNIT CORRECTION BOLUS AT 10:30 PM FOR BLOOD GLUCOSE OF 418 MG/DL AND DID NOT RECHECK HER LEVELS PRIOR TO FALLING ASLEEP. THE PT STATED THAT AROUND 12:00 AM, THE PUMP ALARMED WITH 2 "PUMP IS NOT PRIMED" MESSAGES, SHE RE-PRIMED THE TUBING AFTER EACH WARNING, SHE CANNOT REMEMBER IF SHE DISCONNECTED WHEN SHE RE-PRIMED. SHE NOTICED THAT THE CARTRIDGE CAP WAS LOOSE AFTER THE SECOND LOSS OF PRIME AND SHE TIGHTENED IT BACK ONTO PUMP. AGAIN, SHE CANNOT REMEMBER IF SHE WAS DISCONNECTED AT THAT TIME. THE PRIME HISTORY CONFIRMED THE PT'S RECOLLECTION OF THE EVENTS: THERE WERE PRIME AND FILL CANNULA STEPS COMPLETED AT 11:31 PM AND 12:01 AM FOR A TOTAL OF 5.5 UNITS. THE PT REVIEWED THE PUMP AND THE EVENT. SHE CONFIRMED THAT SHE MOST LIKELY DID NOT FULLY TIGHTEN THE CARTRIDGE CAP AFTER THE MOST RECENT CARTRIDGE CHANGE. SHE DENIED DAMAGE TO THE CARTRIDGE CAP OR COMPARTMENT. SHE SAID SHE COULD TIGHTEN THE CAP SECURELY AND THAT IT WAS TIGHT AT THE TIME OF TROUBLE SHOOTING. THE CAUSE OF THE LOSS OF PRIME WARNINGS WAS DETERMINED TO BE A LOOSE CARTRIDGE CAP. THE PT SAID SHE ALWAYS DISCONNECTS FOR INFUSION SET AND CARTRIDGE CHANGES, BUT SINCE THE EVENT OCCURRED WHILE SHE SLEPT SHE MAY NOT HAVE DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention