BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2170385 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05074
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: NO PUMP DATA FROM THE TIME OF THE EVENT WAS AVAILABLE DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED EXPERIENCING BLOOD GLUCOSE (BG) FROM 46 MG/DL TO 538 MG/DL OVER (B)(6). THE FAMILY MEMBER REPORTED THAT THE PATIENT'S BG WILL BE 56 MG/DL AND THEN REBOUND TO A HIGH IN THE 500'S JUST TO RETURN LOW AFTER BOLUSING. THE PATIENT IS REPORTEDLY GOING THROUGH A (B)(6) AND WAS ON VACATION (B)(6) AND WAS EATING DIFFERENTLY AND WAS MORE ACTIVE THAN USUAL. THE FAMILY MEMBER CONFIRMED THAT THE HISTORY AND SETTINGS WERE CORRECT IN THE PUMP. THE FAMILY MEMBER CONFIRMED THAT THERE WERE NO NOTED SITE ISSUES AND NO ISSUES WITH AIR BUBBLES. CUSTOMER SUPPORT CONCLUDED THAT THERE WERE NO MECHANICAL ISSUES FOUND WITH THE PUMP AND ADVISED THE PATIENT TO HAVE SETTINGS EVALUATED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED ERRATIC BG WHILE USING INSULIN PUMP THERAPY.

    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 12 YR Required Intervention