BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242967 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11741
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/11/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2013 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. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. AN EZBG BOLUS WAS PERFORMED USING THE PATIENT¿S PROGRAMMED SETTINGS FOR A BLOOD GLUCOSE OF 30 MMOL/L AND THE PUMP CALCULATED THE BOLUS CORRECTLY. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS NOT CALCULATING THE CORRECT AMOUNT OF INSULIN FOR THE BOLUSES. THE PATIENT STATED THAT THERE WAS INSULIN ON BOARD AND THE PUMP WAS STILL SHOWING TO TAKE A FULL BOLUS. THE PATIENT REPORTED THAT THE BOLUS RECOMMENDATION APPEARED TO BE MORE THAN IT SHOULD BE. CUSTOMER SUPPORT EXPLAINED HOW THE BLOOD GLUCOSE TARGET FEATURE WORKED AND EXPLAINED THAT THE PUMP SETTINGS WOULD NEED TO BE REVIEWED RELATED TO THE EVENT. THE PATIENT WAS UNABLE TO REVIEW THE PUMP SETTINGS AT THE TIME OF THE CALL. ANIMAS ATTEMPTED TO FOLLOW UP WITH THE PATIENT BUT WAS UNSUCCESSFUL AT THIS TIME. THE PATIENT REPORTED BLOOD GLUCOSE LEVELS AS LOW AS 2.8 MMOL/L WITH NO SYMPTOMS WHICH DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP WAS CALCULATING BOLUS AMOUNTS INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342596 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR