BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2933447 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01303
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4):A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT THE PATIENT WAS HOSPITALIZED FOR A BLOOD GLUCOSE OF 479 MG/DL WITH HIGH KETONES AND VOMITING. THE REPORTER INDICATED THAT THE PATIENT WAS RESPONDING TO INJECTIONS BUT BLOOD GLUCOSE WOULD GO BACK UP WHEN ON THE PUMP. THE REPORTER CONFIRMED NO KNOWN ISSUES WITH THE SITE OR SET. THE PUMP WAS REVIEWED WITH THE PATIENT. THE PATIENT CONFIRMED NO RELEVANT ALARMS, THE BOLUS HISTORY WAS CORRECT, TOTAL DAILY DOSE AMOUNTS WERE CORRECT, THE SUSPEND HISTORY WAS CORRECT, AND THE BASAL HISTORY WAS CORRECT. THE REPORTER STATED THAT THEY HAD LOST FAITH IN THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA RELATED TO A POSSIBLE ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39228 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L