BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1911740 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02505
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. THERE IS NO ALLEGATION OF MALFUNCTION OR DEFECT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO DATA FROM THE DATE OF THE EVENT WAS AVAILABLE DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. PRIOR TO ENTERING THE PRIME MENU, THE PUMP DISPLAYED THE APPROPRIATE WARNING TO DISCONNECT DURING EZPRIME STEPS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE FILLED THE CARTRIDGE TO 200 UNITS, CONNECTED THE TUBING TO THE CARTRIDGE, AND INSERTED THE INFUSION SET INTO HER BODY SITE WHILE THE SET WAS CONNECTED TO THE TUBING AND CARTRIDGE. SHE SAID SHE THEN PLACED THE FILLED CARTRIDGE INTO THE PUMP WHILE STILL CONNECTED TO THE INFUSION SITE. THE PT DOES NOT RECALL IF SHE COMPLETED THE REWIND STEP BEFORE PUTTING THE CARTRIDGE INTO THE PUMP; SHE SAID THAT SHE DID NOT DO THE LOAD CARTRIDGE OR PRIME STEPS. DURING THE CONTACT, THE PT DISCONNECTED FROM THE INFUSION SITE AND PULLED THE CARTRIDGE OUT OF THE PUMP. SHE REPORTED THAT IT WAS EMPTY. THE PT REPORTED THAT HER BLOOD GLUCOSE READING WAS 205 MG/DL AT THE TIME OF THE INCIDENT, SHE CONSUMED QUICK ACTING CARBOHYDRATES, AND RETESTED BLOOD GLUCOSE AT 201 MG/DL. SHE STATED THAT SHE FELT SHAKY. EMERGENCY MEDICAL TRANSPORT WAS CONTACTED AND AN AMBULANCE TOOK THE PT TO THE HOSPITAL. A FAMILY MEMBER REPORTED THAT THE PT WAS TREATED WITH INTRAVENOUS GLUCOSE AND DID NOT LOSE CONSCIOUSNESS. THE PT SAID SHE DOES NOT RECALL HER BLOOD GLUCOSE READINGS, BUT BELIEVED THAT THEY STAYED ABOVE 50 MG/DL. THE FOLLOWING DAY, THE PT REPORTED THAT SHE WAS AWARE OF HER ERROR AND WAS ABLE TO RECALL THE CORRECT SEQUENCE OF STEPS FOR REPLACING THE INFUSION SET AND CARTRIDGE.

    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 68 YR Hospitalization