BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2002536 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00883
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FAMILY MEMBER NOTED THAT THE BATTERY COMPARTMENT AND CAP WERE UNDAMAGED; SHE ALSO REPORTED THAT THE BATTERY CAP WAS ABOUT NINE MONTHS OLD. REVIEW OF ORDERS CONFIRMED THAT THE MOST RECENT SHIPMENT OF A REPLACEMENT BATTERY CAP WAS ON (B)(6) 2009. AT THAT TIME THE ACTIVITY NOTES INDICATED THAT A FAMILY MEMBER ORDERED THE CAP AS A SPARE TO BE SUED WHEN THE CURRENT CAP HAD EXPIRED. THIS EVIDENCE INDICATES THAT THE CAP MAY HAVE BEEN OLDER THAN NINE MONTHS. THE OWNER'S BOOKLET ADVISES PUMP USERS TO REPLACE THE BATTERY CAP EVERY SIX MONTHS OR MORE FREQUENTLY IF IT IS FREQUENTLY EXPOSED TO WATER OR DUST. THE PUMP WAS RETURNED TO ANIMAS EVALUATION. STRIPPED THREADS WERE OBSERVED ON THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP. EVALUATION REVEALED THIS CAP WAS UNABLE TO FULLY TIGHTEN AND EASILY DETACHED FROM THE PUMP. INVESTIGATION REVEALED AN INTERMITTENT LOSS OF CONTACT BETWEEN THE BATTERY CAP AND THE PUMP CASE. USING A TEST CAP, THE PUMP WAS EXERCISED FOR 48 HOURS WITH NO POWER LOSS. NO INTERNAL POWER RELATED DEFECTS WERE FOUND. THE BLACK BOX VERIFIED A POWER INTERRUPTION ON (B)(6) 2011, AT 9:37 PM THAT WAS NOT RESUMED BY THE USER UNTIL (B)(6) 2011 AT 7:48 AM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BLOOD GLUCOSE OF 497 MG/DL AND WAS POSITIVE FOR KETONES WITH NO OTHER SYMPTOMS OF HYPERGLYCEMIA. A FAMILY MEMBER STATED THAT THE PUMP POWERED OFF WHILE THE PT SLEPT. SHE OBSERVED THAT THE DISPLAY SCREEN WAS BLANK AND THE PUMP HAD NO POWER; SHE NOTED THAT THE EVENT IS THE SECOND INSTANCE OF A SPONTANEOUS POWER LOSS. THE FAMILY MEMBER CHANGED THE BATTERY AND THE PUMP POWERED ON AS EXPECTED. THERE WERE NO ASSOCIATED ALARMS IN HISTORY. SHE STATED THAT THE BATTERY CAP WAS SECURE AND INTACT, THERE WAS NO YELLOW O-RING VISIBLE, AND THE BATTERY CAP WAS ABOUT 9 MONTHS OLD. THE FAMILY MEMBER SAID THAT THE BATTERY COMPARTMENT THREADS ARE INTACT AND THERE ARE NO CRACKS IN CASING. SHE CONFIRMED THAT THE BATTERY CAP WAS SECURE AND THE YELLOW O-RING WAS NOT VISIBLE AT THE TIME OF THE POWER LOSS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention