BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3832768 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14826
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    March 19, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/23/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND NO COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA DID NOT FIND EVIDENCE OF TIME/DATE RESETTING TO DEFAULT. THE TOTAL DAILY DELIVERY CORRECTLY REFLECTED THE PROGRAMED BASAL RATE. THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR BASAL EXERCISE WERE EXECUTED WITHOUT INCIDENTS. THE PUMP DELIVERY ACCURACY WAS WITHIN SPECIFICATIONS AND THE BOLUS DELIVERY EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. EVALUATION REVEALED THAT THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD MALFUNCTIONED. 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. THE REPORTED TIME/DATE RESET ISSUE WAS NOT VERIFIED IN THE BLACK BOX BUT DUPLICATED IN THE INVESTIGATION. UNRELATED TO THE TIME/DATE RESET ISSUE, IT WAS OBSERVED THAT THE TEXT ON THE VERIFY SCREEN WAS DISCOLORED. IN ADDITION, THE BATTERY COMPARTMENT WAS CRACKED AT THE BASE SEAL.

    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 ON (B)(6) 2014 HE EXPERIENCED LOW BLOOD GLUCOSE (BG) OF 50 MG/DL WITH COGNITIVE IMPAIRMENT. THE PATIENT WAS REPORTEDLY ABLE TO SELF-TREAT WITH GLUCOSE AND REMAINED ON THE PUMP. THE PATIENT STATED THAT THE TIME AND DATE ON THE PUMP REVERT TO DEFAULT SETTINGS WHEN THE BATTERY IS REMOVED FOR LESS THAN 24 HOURS. USE ERROR WAS DETERMINED TO BE A CONTRIBUTING FACTOR, AS THE PUMP PROMPTS THE USER TO CONFIRM THE TIME AND DATE SETTINGS WHEN THE PUMP IS REBOOTED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA ASSOCIATED WITH A TIME/DATE RESET AND USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310763 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening