BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4131561 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28001
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 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. ON INVESTIGATION, THE ALLEGED BATTERY LIFE ISSUE WAS NOT DUPLICATED. REVIEW OF BLACK BOX DATA FOUND THAT THE AVAILABLE DATE RANGE DID NOT COVER THE COMPLAINT DATE DUE TO CONTINUED CUSTOMER USE. NO UNUSUAL ACTIVITIES WERE FOUND IN THE AVAILABLE DATE RANGE. THE TOTAL DAILY DELIVERY ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL RATES. BATTERY CAP WAS NOT RETURNED AND A TEST CAP WAS USED IN THE EVALUATION. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUES WERE FOUND WITH THE BUTTONS. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR BASAL EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE PUMP DELIVERY ACCURACY AND ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE REPORTED EMPTY CARTRIDGE ALARM WAS DUPLICATED. AN EMPTY CARTRIDGE ALARM WAS DUPLICATED DURING TESTING AND THE PUMP ALARMED APPROPRIATELY WITH AUDIBLE AND VISUAL WARNINGS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN 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 REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON PUMP THERAPY. REPORTEDLY, ON AN UNSPECIFIED DATE, THE PATIENT¿S BLOOD GLUCOSE (BG) READING WAS AT 300 MG/DL WITH NAUSEA, ATYPICAL THIRST AND TRACE LEVEL OF KETONES. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE PATIENT ALLEGEDLY REMAINED ON PUMP THERAPY WITH NO RECENT ADJUSTMENT TO THE PUMP SETTINGS. CUSTOMER TECHNICAL SUPPORT AGENT REVIEWED THE EVENT WITH THE REPORTER. IT WAS REPORTED THAT THE BATTERY LIFE WAS LESS THAN EXPECTED. THE REPORTER STATED THAT THE CORRECT BATTERY TYPE WAS USED AND IT MATCHED THE SETTINGS IN THE PUMP. REVIEW OF THE PUMP HISTORY REVEALED THAT THERE WERE UNCONFIRMED EMPTY CARTRIDGE WARNINGS. IT WAS FURTHER REVEALED THAT THE PATIENT FAILED TO RESPOND TO THE WARNING THROUGHOUT THE NIGHT BECAUSE THEY DID NOT HEAR THE ALARM. THE REPORTER VERIFIED THAT THE SETTINGS WERE ON ¿HIGH¿ FOR ALARMS AND THAT THE AUDIO FEATURE WAS FUNCTIONING PROPERLY WITH A MOCK BOLUS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA ASSOCIATED WITH A USE ERROR IN THAT ALARMS WERE NOT CONFIRMED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612722 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening