BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1962723 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00093
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO ANIMAS. THERE WAS NO EVIDENCE OF A PUMP MALFUNCTION. THE ANIMAS REP REVIEWED THE LOCK FEATURE OF THE PUMP WITH THE REPORTER AND EXPLORED POSSIBLY SETTING THE BOLUS LIMIT TO 0 UNITS AT NIGHT. THE PT MAY HAVE INADVERTENTLY PROGRAMMED THE ADD'L DOSE CAUSING HER BLOOD GLUCOSE LEVELS TO DROP.

    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: THERE WERE NO ALARMS NOTED RELATED TO THE COMPLAINT IN THE PUMP ALARM HISTORY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES UP UNTIL THE REPORTED EVENT DATE. TYPICAL USAGE ALARMS AND WARNINGS WERE NOTED IN THE BLACK BOX HISTORY. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATION. THE "EZPRIME" OPERATION WAS PERFORMED WITH NO ISSUES NOTED. THE REWIND, PRIME AND LOAD STEPS WERE SUCCESSFULLY PERFORMED ON THE PUMP. THE UNITS REMAINING WERE CORRECTLY CALCULATED AND ACCURATELY RECORDED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, A TIME/DATE RESET WAS NOTED AFTER A BATTERY CHANGE. 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. THIS COMPLAINT WAS UNABLE TO BE ADEQUATELY INVESTIGATED DUE TO OVERWRITTEN DATA IN THE BLACK BOX HISTORY.

    Description of Event or Problem · 1

    THE PT'S FATHER REPORTED THAT THE PT WENT TO THE EMERGENCY ROOM IN THE MORNING DUE TO AN ADD'L BOLUS DOSE WHILE THE PT WAS SLEEPING. THE PT'S FATHER WANTED INSTRUCTION ON HOW TO DISABLE THE AUDIO BOLUS BUTTON WHEN THE PT IS SLEEPING. THE PT'S FATHER FOUND THE PT WITH A BLOOD GLUCOSE LEVEL OF 50 MG/DL IN THE MORNING. THE PT HAD CONVULSIONS AND LOST CONSCIOUSNESS. THE PT'S FATHER TURNED THE PUMP OFF AND GAVE THE PT SOME ORANGE JUICE AND A GLUCOSE TABLET. HE BELIEVES THAT THE EMT'S MAY HAVE TREATED THE PT WITH SOMETHING ELSE INTRAVENOUSLY BEFORE TAKING HER TO THE EMERGENCY ROOM. THE REPORTER THINKS THE PT MAY HAVE PROGRAMMED THE EXTRA BOLUS DOSE IN HER SLEEP. SHE DOES NOT REMEMBER PROGRAMMING THE EXTRA DOSE BUT REMEMBERS THAT SHE HAD A PIE PRIOR TO BEDTIME AND HER FATHER WONDERS IF SHE WAS DREAMING ABOUT IT AND PROGRAMMED AN ADD'L BOLUS DOSE. HE ALSO MENTIONED THAT THE PT HAS HISTORY OF SLEEP WALKING AND SLEEP TALKING.

    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 12 YR Hospitalization| L| R