BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3834075 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14861
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 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 SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND MULTIPLE LOW AND REPLACE BATTERY WARNINGS, EVIDENCES OF EXCESSIVE BATTERY USAGE. THE BATTERY COMPARTMENT WAS INTACT AND THE PUMP PASSED A LEAK TEST. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. THE ELECTRICAL CURRENT DRAWS WERE OUT OF SPECIFICATIONS. THE PUMP CASING WAS OPENED AND NO INTERNAL MOISTURE DAMAGES WERE FOUND. FURTHER EVALUATION REVEALED THAT A COMPONENT ON THE PRINTED CIRCUIT BOARD MALFUNCTIONED AND REPLACING THE DEFECTIVE COMPONENT RETURNED THE CURRENT DRAWS TO WITHIN SPECIFICATIONS. UNRELATED TO THE COMPONENT ISSUE, MOISTURE CONTAMINATION WAS FOUND UNDER THE BATTERY CAP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING AN ISSUE WITH RECURRING LOW/REPLACE BATTERY WARNINGS WITH MULTIPLE BATTERIES FROM DIFFERENT BOXES. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311485 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR