BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2760292 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11252
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUBMITTED (B)(4) 2012 FOLLOW-UP #1: THE PUMP WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING RESULTS: NO DEFECTS WERE FOUND WITH THE RETURNED PUMP. PUMP POWERS ON WITH AUDIBLE AND VIBRATORY SOUNDS. THERE WERE NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION RECORDED IN BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED. PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM; NO WARNING OR ALARMS OCCURRED DURING THIS TIME. A NORMAL 10 UNIT BOLUS WAS PERFORMED SUCCESSFULLY AND WAS ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD WAS TESTED AND ALL KEYS ARE RESPONSIVE TO USER INPUT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING THAT THE PUMP WAS DELIVERING INSULIN INACCURATELY. THE REPORTER LEFT A MESSAGE REPORTING AN ELEVATED BLOOD GLUCOSE (BG) EXCURSION. THE PATIENT REPORTEDLY HAD SOME ELEVATED BG'S. NO SPECIFIC BG VALUES WERE PROVIDED. ATTEMPTS BY ANM TO CONTACT THE REPORTER FOR FOLLOW-UP INFORMATION AND TROUBLESHOOTING OF THE PUMP HAVE BEEN UNSUCCESSFUL. HOWEVER, ON (B)(6) 2012, THE PATIENT'S FATHER CONTACTED ANM AND REPORTED THAT THE PUMP'S AUDIO BOLUS BUTTON WAS MISSING/TORN OFF. THE PATIENT'S FATHER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED BUTTON ISSUE. THE PATIENT'S FATHER DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INITIAL CONTACT MADE BY THE PATIENT'S MOTHER FROM (B)(6) 2012. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MOTHER ALLEGED THAT THE PUMP WAS NOT DELIVERING INSULIN ACCURATELY. HOWEVER, THERE IS NO EVIDENCE THAT THE PUMP CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS, AND/OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR