BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3940239 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20382
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/27/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND LOW AND REPLACE BATTERY WARNINGS ALONG WITH EVIDENCE OF A BATTERY WITH LOW VOLTAGE BEING INSTALLED. THE CAP WAS UNABLE TO SECURE PROPERLY ONTO THE PUMP BUT WAS ABLE TO MAINTAIN ELECTRICAL CONTACTS TO ALLOW THE PUMP TO POWER UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. THE ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE REPORTED BATTERY LIFE ISSUE WAS NOT DUPLICATED IN THE INVESTIGATION AND WAS ATTRIBUTED TO A USE ERROR IN THAT A PARTIALLY DISCHARGED BATTERY WAS BEING INSTALLED. UNRELATED TO THE REPORTED ISSUE, THE COMPARTMENT WAS FOUND TO HAVE CRACKED IN THE THREADS AREA AND BELOW THE GRIP PAD. REMOVAL OF THE PUMP CASING DID NOT FIND ANY EVIDENCE OF MOISTURE INTRUSION OR LOOSE COMPONENT INSIDE THE PUMP.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. REPORTEDLY, THE BATTERY LIFE WAS LESS THAN EXPECTED SINCE ABOUT 2 MONTHS AGO. THE REPORTER STATED THAT THE CORRECT BATTERY TYPE WAS USED AND IT MATCHED THE BATTERY SETTING. THE ISSUE ALLEGEDLY HAD OCCURRED WITH MULTIPLE BATTERIES FROM DIFFERENT PACKS. 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
    418364 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR