BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2180049 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05290
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON APPROPRIATELY WITH NO ALARMS. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR ALARMS OCCURRING. THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP AND COMPARTMENT, AND NO BATTERY CAP CONNECTION DEFECTS WERE OBSERVED DURING TESTING. THE BATTERY CAP WAS ABLE TO SECURE APPROPRIATELY TO THE PUMP. THERE WAS NO DAMAGE OBSERVED TO THE POWER CIRCUIT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. 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 REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) READING OF "HI" (GREATER THAN 600 MG/DL AFTER THE PUMP LOST POWER WITHOUT WARNING THE AFTERNOON OF (B)(6) 2011. HE STATED THAT THE PATIENT HAD NOT IMPLEMENTED AN ALTERNATE INSULIN DELIVERY PLAN SINCE THE PUMP LOST POWER. (B)(4) ADVISED THAT THE PATIENT CONTACT HIS HEALTH CARE PROVIDER FOR A BACK UP PLAN. THE FAMILY MEMBER DENIED THAT ANY ALARMS OCCURRED PRIOR TO THE PUMP LOSING POWER. HE REPORTED THAT THE PATIENT CHANGED THE BATTERY AND THE PUMP WOULD STILL NOT POWER ON; HE STATED THAT THE BATTERY WAS CHANGED A SECOND TIME, AND THE PUMP POWERED UP TO THE VERIFICATION SCREEN. THE FAMILY MEMBER NOTED THAT THE PATIENT WAS UNABLE TO NAVIGATE BEYOND THE VERIFICATION SCREEN DUE TO UNRESPONSIVE KEYPAD BUTTONS. THE UNRESPONSIVE BUTTON ISSUE IS ADDRESSED THROUGH A SEPARATE COMPLAINT. THE FAMILY MEMBER CONFIRMED THAT THE BATTERY CAP WAS TIGHTENED TO RESISTANCE, THERE WAS NO STRUCTURAL DAMAGE TO THE BATTERY CAP OR THE BATTERY COMPARTMENT, AND THERE WAS NO VISIBLE CORROSION IN THE BATTERY COMPARTMENT. HE NOTED THAT THE BATTERY CAP WAS LAST CHANGED OVER (B)(6) AGO. THE USER GUIDE ADVISES THAT THE BATTERY CAP BE CHANGED EVERY SIX MONTHS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA AFTER THE PUMP LOST POWER.

    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 13 YR Required Intervention