BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2101678 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03668
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 24, 2011
    Report Date
    May 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 CONFIRMED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THERE WERE NO ALARMS INDICATING A MALFUNCTION RECORDED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE (BG) OF 23 MG/DL AND PASSED OUT ON (B)(6) 2011. SHE STATED THAT SHE WAS TREATED WITH A GLUCAGON INJECTION ADMINISTERED BY HER BOYFRIEND. THE PATIENT REPORTED THAT HER BG'S HAVE RANGED BETWEEN 43 MG/DL AND 414 MG/DL ON (B)(6) 2011. SHE REPORTED THAT THERE WERE NO SYMPTOMS AND NO KETONES. ANIMAS CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND FOUND THAT ALL SETTINGS AND HISTORY ARE CORRECT. THERE WERE NO SITE ISSUES AND NO MECHANICAL PROBLEMS FOUND WITH THE PUMP. THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THE PATIENT HAS CONTINUED USING THE PUMP WITH NO FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPOGLYCEMIA ON (B)(6) 2011 WHILE USING THE PUMP.

    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 41 YR Life Threatening| R