BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132553 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07124
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/25/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/27/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING THE PUMP POWERED ON WITH AUDIO AND VIBRATION WORKING APPROPRIATELY. THE AUDIBLE SOUND LEVEL WAS TESTED AND FOUND TO PASS SPECIFICATIONS. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE SOUND CIRCUIT. THE COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT WHEN HE AWOKE AT 6AM, THE PUMP REPORTEDLY MADE A STRANGE NOISE AND WHEN HE CHECKED THE PUMP, THE DISPLAY SCREEN WAS BLANK. THE PATIENT REPORTEDLY REPLACED THE BATTERY AND THE PUMP RESTORED POWER. THE PATIENT STATED THAT THE PUMP DID TO EMIT A BATTERY LIFE ISSUE. THERE WAS REPORTEDLY SOUND AFTER THE BATTERY WAS REPLACED BUT THE PATIENT STATED THE SOUND WAS INTERMITTENT. IT WAS NOTED AT THE TIME CUSTOMER SUPPORT (CS) WAS TROUBLESHOOTING THE PUMP, THE SOUND AND VIBRATORY FEATURE OF THE PUMP WAS WORKING. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED DUAL ALARM ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234500 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR