BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2973919 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02030
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY 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. THE PUMP HISTORY SHOWED THAT THE PUMP ALARMED ¿REPLACE CARTRIDGE¿ WHICH WAS CONFIRMED 15 TIMES. THE PUMP DELIVERY WAS NOT RESUMED WITH A NEW CARTRIDGE FOR 2 HOURS AND 39 MINUTES. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS; THE PATIENT WAS REPORTED TREATED WITH INTRAVENOUS INSULIN AND FLUIDS. THE REPORTER INDICATED THAT THE PATIENT'S BLOOD GLUCOSE UPON ADMISSION WAS 594 MG/DL WITH KETONES, NAUSEA, AND VOMITING. THE REPORTER CONFIRMED THAT THE PUMP SETTINGS WERE PROGRAMMED CORRECTLY. TROUBLESHOOTING OF THE PUMP FOUND THAT THERE WERE NO MECHANICAL ISSUES WITH THE PUMP RELATED TO THE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78092 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L