BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2911466 · Received January 11, 2013

    Report

    Report Number
    2531779-2013-00555
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS MULTIPLE INSTANCES OF THE TIME AND DATE RESETTING TO DEFAULT FOLLOWING A REBOOT. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO THE TIME AND DATE ISSUE. VISUAL INSPECTION FOUND CORROSION INSIDE THE BATTERY COMPARTMENT. THERE WERE NO LEAKS OBSERVED DURING LEAK TESTING. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. 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.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF OVER 600MG/DL AND EXPERIENCED CRAMPS IN LEGS AND WAS HOSPITALIZED. THE PATIENT REPORTEDLY WAS TREATED VIA CORRECTION INJECTION AND THE PATIENT'S BG WENT DOWN TO 503MG/DL. THE PATIENT STATED THAT SHE HAD ISSUES WITH LOW BATTERY AND HAS BEEN CHANGING BATTERIES FREQUENTLY. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND THE REPORTER AND NOTED IN PUMP HISTORY THAT THE TIME AND DATE WERE CORRECT FOR A FEW HOURS ON (B)(6) 2012 BUT PRIOR TO THIS DATE; THE DATE HAD A RECORD OF (B)(6) 2007. THE PUMP REPORTEDLY EMITTED SEVERAL "LOW BATTERY", "REPLACE BATTERY" AND CALL SERVICE ALARMS. THE DATE AND TIME WERE REPORTEDLY UNABLE TO BE DETERMINED ON ANY OF THE EMITTED ALARMS. CS ADVISED THE PATIENT THAT THIS COULD BE THE REASON FOR THE PATIENT'S BG ELEVATIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION OF A TIME/DATE ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16889 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| L| R