BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2832261 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13603
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 [DATE OF SUBMISSION 01/03/2013]-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: DURING EVALUATION BOLUSES WERE PROGRAMMED AND DELIVERED AND WERE RECORDED CORRECTLY IN THE PUMP HISTORY. THERE WERE NO DEFECTS FOUND WITH THE PUMP DURING EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT THAT HIS BLOOD GLUCOSE (BG) LEVELS HAD BEEN HIGHER THAN NORMAL SINCE STARTING ON THE PUMP 3 WEEKS PRIOR. THE PATIENT STATED THAT SINCE STARTING ON THE PUMP HE WAKES UP WITH A BG ABOVE 200 MG/DL AND AFTER BREAKFAST HIS BGS WOULD BE IN THE 300 MG/DL RANGE. THE PATIENT DENIED DEVELOPING SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WITH THE ELEVATED BG READINGS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY ISSUES WITH SITE OR INFUSION SET. WHILE REVIEWING BOLUS HISTORY, THE PATIENT REPORTED THAT A BOLUS RECORD WAS MISSING. THE PATIENT STATED HE TOOK A 4 UNIT AUDIO BOLUS AT 10:30 AM THAT MORNING, WHICH WAS NOT RECORDED IN THE PUMP'S BOLUS HISTORY. THE PATIENT WAS ADVISED BY CUSTOMER SUPPORT TO DISCONNECT FROM PUMP AND GO TO BACKUP PLAN. THE PATIENT'S REPORTED BG READING(S) DO NOT MEET ANIMAS CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WITH THE MISSING BOLUS RECORD REMAINED UNRESOLVED.

    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 30 YR