BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232755 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06434
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO DATA FROM THE TIME OF THE EVENT WAS AVAILABLE DUE TO CONTINUED PATIENT USE. NO PERFORMANCE TESTING WAS ABLE TO BE COMPLETED DUE TO THE OK BUTTON BEING UNRESPONSIVE TO PRESSES; THE KEYPAD WAS FOUND TO BE PEELING AT THE CONTRAST BUTTON. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE BUTTON CONTACTS.

    Additional Manufacturer Narrative · 1

    A PUMP RETURN IS NOT EXPECTED AS NO MALFUNCTION OR DEFECT WAS ALLEGED OR DISCOVERED. THE INFUSION SET IS BEING RETURNED WITH PI #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) OF 600MG/DL WITHOUT SYMPTOMS; TRACE KETONES WERE PRESENT. CUSTOMER SUPPORT DETERMINED THE FOLLOWING SEQUENCE OF EVENTS: THE PATIENT CHANGED THE INFUSION SET AT 2:30AM, THE PUMP EMITTED AN OCCLUSION ALARM AT 8:34AM, AND THE PATIENT PRIMED THE PUMP WITHOUT REPLACEMENT OF THE INFUSION SET, TUBING, OR CARTRIDGE. A FAMILY MEMBER REPORTED THAT THE PATIENT WAS TREATED WITH INSULIN VIA SYRINGE AT ABOUT 2:30PM; THE INFUSION SET AND TUBING WAS REPLACED AROUND 3:30PM UPON THE ADVICE OF CUSTOMER SUPPORT. DURING TROUBLESHOOTING, THE PATIENT WAS ABLE TO REWIND, LOAD, AND PRIME AFTER THE SUPPLIES WERE REPLACED. THE DATE, TIME, AND BATTERY TYPE WERE SET CORRECTLY. THE BASAL RATE WAS DISPLAYED ACCURATELY ON THE HOME SCREEN. NO MECHANICAL ISSUE WAS FOUND WITH THE ANIMAS PUMP. THE LIKELY CAUSE OF THE OCCLUSION WAS A BLOCKAGE IN THE INFUSION SET CANNULA OR TUBING ALTHOUGH, THERE WAS NO REPORT OF VISIBLE BENDS OR KINKS. THIS COMPLAINT WAS FORWARDED TO THE MANUFACTURER OF THE INFUSION SET PRODUCTS. THE COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT'S BG ELEVATION WAS THE RESULT OF THE FACT THAT THE INFUSION SET AND TUBING WERE NOT REPLACED AFTER THE OCCLUSION ALARM. CUSTOMER SUPPORT REMINDED THE PATIENT AND THE FAMILY MEMBER TO REMOVE AND REPLACE SUPPLIES AFTER AN OCCLUSION ALARM IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening