BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3803128 · Received May 9, 2014

    Report

    Report Number
    2531779-2014-13128
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX COULD NOT CONFIRM THE ALLEGATION OF A TIME/DATE RESET. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE PUMP WAS RUNNING ON THE INCORRECT TIME/DATE SINCE (B)(6) 2014. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. 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. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT CONTACTED ANIMAS ALLEGING THAT HE WAS TREATED IN THE HOSPITAL ON (B)(6) 2014 FOR BLOOD GLUCOSE (BG) OVER 250MG/DL WITH NAUSEA AND SYMPTOMS OF DEHYDRATION. THE PATIENT WAS REPORTEDLY TREATED WITH IV GLUCOSE AND IV FLUIDS AND THE PATIENT REPORTEDLY DISCONTINUED INSULIN PUMP THERAPY. THE PATIENT NOTED THAT THE PUMP¿S TIME AND DATE RESET TO DEFAULT SETTING WHEN THE BATTERY WAS OUT OF THE PUMP FOR LESS THAN 24 HOURS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY ASSOCIATED WITH A TIME/DATE ISSUE. USE ERROR CANNOT BE RULED OUT AS A CONTRIBUTOR IN THE ALLEGED INCIDENT, AS THE PUMP PROMPTS THE USER TO CONFIRM THE TIME AND DATE WHEN THE PUMP IS REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281660 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R