BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4210360 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30757
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 12/26/2014 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/08/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED EVIDENCE OF VOLTAGE FLUCTUATIONS, BATTERY ALARMS, AND TWO CS 128 REPLACE BATTERY ALARMS OCCURRING. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED IN THE THREAD AREA AND BELOW THE GRIP PAD. EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE RETURNED BATTERY CAP WAS NOT ABLE TO BE FULLY SECURED TO THE PUMP BUT WAS ABLE TO MAINTAIN AN ELECTRICAL CONNECTION WITH THE PUMP. THE PUMP¿S ELECTRICAL CURRENT DRAWS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE DISPLAY WAS DIM AND DISCOLORED. ALSO UNRELATED TO THE COMPLAINT EVALUATION REVEALED THAT ALL KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS INTACT NO DAMAGE WAS OBSERVED. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. THE COMPLAINT OF SHORT BATTERY LIFE WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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 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 W/ DAMAGE) ISSUE. THE REPORTER ALLEGED THAT HE BATTERY COMPARTMENT WAS CRACKED AND THAT THE BATTERY CAP HAD NOT BEEN REPLACED IN FOUR TO SIX MONTHS. 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
    692005 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR