BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2922601 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00863
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/09/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/28/2016 WITH THE FOLLOWING FINDINGS:THERE WAS NO PUMP DATA FROM THE TIME OF THE EVENT DUE TO CONTINUED PATIENT USE OF THE PUMP. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE 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 DELIVERY ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING BLOOD GLUCOSE LEVELS FROM 3 TO 4 MMOL/L WITH FEELING HOT, SWEATING, SHAKING, AND INCREASED HUNGER ON (B)(6) 2013. THE PATIENT REPORTEDLY CONTACTED A HEALTH CARE PROFESSIONAL WHO ADVISED THE PATIENT TO USE A TEMPORARY BASAL, AND ADJUST THE TARGET BLOOD GLUCOSE, INSULIN TO CARBOHYDRATE, AND INSULIN SENSITIVITY FACTOR SETTINGS IN THE PUMP. THE PATIENT INDICATED THAT AFTER THE ADJUSTMENTS WERE MADE BLOOD GLUCOSE LEVELS WERE STILL LOW. THE PUMP WAS REVIEWED WITH THE PATIENT. THE PATIENT CONFIRMED THAT THE BASAL RATES AND ADVANCED SETTINGS WERE PROGRAMMED CORRECTLY. THE PATIENT INDICATED THAT THERE WERE NO RELEVANT ALARMS IN THE PUMP HISTORY. THE TOTAL DAILY DOSE HISTORY WAS REVIEWED AND CORRECTLY REFLECTED THE BASAL AND BOLUS AMOUNTS. THE PATIENT WAS ADVISED THAT THERE WAS NO INDICATION OF A PUMP MECHANICAL ISSUE RELATED TO THE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27543 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening