BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2202449 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05796
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THERE WAS NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HOSPITALIZATION DUE TO CONTINUED USE.

    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. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE EXPERIENCED AN LOW BLOOD GLUCOSE (READING UNKNOWN) AND WAS ADMINISTERED GLUCAGON BY EMT AND TAKEN TO THE HOSPITAL. THE PATIENT WAS REPORTEDLY TREATED WITH SUGAR TABLETS AND RELEASED. THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE EXPERIENCED A BLOOD GLUCOSE OF 1.6 MMOL/L WHICH WAS SELF TREATED WITH ORAL CARBOHYDRATES. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE PATIENT. THE PATIENT CONFIRMED THAT THE SETTINGS WERE CORRECT. THE PATIENT REPORTED THAT THE SETTINGS WERE NOT ADJUSTED. THE PATIENT CONFIRMED THAT THE BOLUS HISTORY WAS CORRECT WHICH INDICATED THAT TWO HOURS PRIOR TO THE LOW BLOOD GLUCOSE ON (B)(6) 2011. THE PATIENT CONFIRMED THAT THE PRIME HISTORY WAS CORRECT WHICH SHOWED THREE PRIMES ON (B)(6) 2011; THE PATIENT STATED THAT SHE WAS NOT CONNECTED DURING ANY PRIMES. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND THERE WERE NO TEMP BASAL RATES. THE PATIENT CONTINUED ON THE PUMP AND THERE HAVE BEEN NO FURTHER REPORTED BLOOD GLUCOSE EXCURSIONS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA 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 51 YR Required Intervention