BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2070209 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02912
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO DATA IN THE PUMP HISTORY FROM THE TIME OF THE EVENT 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

    THE PATIENT REPORTED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE (BG) VALUES AT NIGHT DURING A TWO WEEK PERIOD OF TIME; SHE SAID SHE WOKE UP WITH BG READINGS BETWEEN 22 MG/DL AND 71 MG/DL. THE PATIENT REPORTED THAT EACH TIME SHE EXPERIENCED A SYMPTOM SHE DESCRIBED AS JITTERY AND TREATED HERSELF WITH ORAL CARBOHYDRATES TO RESOLVE THE LOW BG EPISODES. SHE SAID THAT SHE BEGAN TO DISCONNECT FROM THE PUMP AT BEDTIME TO PREVENT THE BG EXCURSIONS. CUSTOMER SUPPORT REVIEWED THE PUMP AND DISCOVERED THAT THE DATE AND TIME WERE INCORRECTLY PROGRAMMED. FURTHER REVIEW OF THE PUMP INDICATED THAT THE PATIENT WOULD RECEIVE EVEN HIGHER BASAL RATES IF THE TIME ISSUE WERE CORRECTED. CUSTOMER SUPPORT ADVISED THE PATIENT TO CONTACT HER HEALTH CARE PROVIDER TO REVIEW SETTINGS PRIOR TO RESUMPTION OF PUMP THERAPY. THE PATIENT CONFIRMED ACCURATE CARBOHYDRATE COUNTING, SAID THAT SHE DELIVERS BOLUSES 15 MINUTES PRIOR TO CARBOHYDRATE INTAKE, AND STATED THAT SHE DOES NOT TEST BG AT TIME OF CARBOHYDRATE BOLUSES. SHE DENIED ALCOHOL CONSUMPTION AND REPORTED NO UNPLANNED ACTIVITY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE INCIDENTS OF HYPOGLYCEMIA WERE LIKELY RELATED TO USER ERROR IN REGARDS TO INCORRECT BASAL RATE PROGRAMMING AND INAPPROPRIATE BOLUS DELIVERY PRACTICES.

    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 65 YR Life Threatening