BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2880290 · Received December 19, 2012

    Report

    Report Number
    2531779-2012-14876
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. THE USERS PROGRAMMED BASAL RATES ARE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS; SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED IN THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON (B)(6) 2012 THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 585 MG/DL AND HE ALLEGED THE PUMP WAS NOT DELIVERING INSULIN. THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT REPLACED THE INFUSION SET AND INFUSION SITE AND CLAIMED HE WAS UNABLE TO CORRECT HIS BLOOD GLUCOSE LEVELS USING THE PUMP. THE PATIENT TOOK BOLUS DOSES OF INSULIN VIA A SYRINGE INJECTION TO LOWER HIS BLOOD GLUCOSE LEVELS. TROUBLESHOOTING REVEALED ALL PUMP SETTINGS, PROGRAMMING, BASAL RATE AND DATE/TIME WERE CORRECT, AND THE TOTAL DAILY DOSES GIVEN CORRECTLY MATCHED THOSE PROGRAMMED. THERE WERE NO ISSUES REPORTED WITH THE INFUSION SET OR INFUSION SITE. THE ISSUE WAS NOT RESOLVED. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA WHILE USING THE PUMP, AND RECEIVED MANUAL INJECTIONS OF INSULIN TO CORRECT HIS BLOOD GLUCOSE LEVELS. THERE WAS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN. HOWEVER, AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening