BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982282 · Received February 1, 2011

    Report

    Report Number
    2531779-2011-00544
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 1, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS THE RESULT OF THE PT IGNORING ALARMS THAT ALERTED HER TO THE FACT THAT THE BATTERY NEEDED TO BE REPLACED. THERE IS NO EVIDENCE OF PUMP MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/07/2014 WITH THE FOLLOWING FINDINGS: A CRACK WAS OBSERVED AT CASE SEAL OF BATTERY COMPARTMENT. THE TOTAL DAILY DOSE IN CURRENT PUMP HISTORY ADDS UP CORRECTLY. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST. THE DISPLAY SCREEN HAS A FADED PINKISH CONTRAST AND THE SCREEN IS STILL ABLE TO BE READ. 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. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BLOOD GLUCOSE LEVEL OF 600 MG/DL; THE PT DID NOT REPORT SYMPTOMS OF HYPERGLYCEMIA OR DKA. THE PT REPORTED THAT SHE WOKE UP WITH NO POWER TO THE PUMP. SHE STATED THAT THE BATTERY CAP WAS SECURE TO THE PUMP AND REBOOTING THE PUMP HAD NOT EFFECT ON THE POWER. THE PT PLACED A NEW BATTERY INTO THE BATTERY COMPARTMENT AND REBOOTED THE PUMP; THE PUMP POWERED UP AS EXPECTED. SHE REVIEWED THE ALARM HISTORY AND DISCOVERED A LOW BATTERY WARNING AT 3:00 AM AND THEN A REPLACE BATTERY ALARM AT 5:00 AM. CUSTOMER SUPPORT EXPLAINED TO THE PT THAT THE BATTERY HAD LOST CHARGE AND THE PUMP ALARMED APPROPRIATELY. THE PT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. THIS EVENT IS BEING REPORTED BECAUSE OF THE USER ERROR LEADING TO A SERIOUS HYPERGLYCEMIC EVENT.

    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 54 YR Required Intervention