BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2862141 · Received December 7, 2012

    Report

    Report Number
    2531779-2012-14295
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. NO UNPROGRAMMED BOLUSES OCCURRED DURING TESTING. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES FROM THE BASAL HISTORY. BOLUS HISTORY VERIFIES REPORTED BOLUSES. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. NO DAMAGE FOUND TO THE KEYPAD. ALL BUTTONS RESPOND TO PRESSES APPROPRIATELY. THE KEYPAD WAS REMOVED; NO DAMAGED/MISALIGNED CONTACTS FOUND, NO EVIDENCE OF CONTAMINATION FOUND UNDER THE BUTTON CONTACTS.

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PATIENT HAD A BLOOD GLUCOSE OF 34 MG/DL WITH UNRESPONSIVENESS, CONVULSIONS, AND VOMITING. THE REPORTER STATED THAT EMERGENCY MEDICAL SERVICES TREATED THE PATIENT WITH INTRAVENOUS GLUCOSE. THE REPORTER INDICATED THAT THE PATIENT GAVE A BOLUS OF 8 UNITS BEFORE EATING. WHEN THE BOLUS HISTORY WAS REVIEWED, THE BOLUS HISTORY REFLECTED A BOLUS OF 11 UNITS AT THAT TIME. ADDITIONALLY, THE REPORTER INDICATED THAT THERE WERE MULTIPLE BOLUSES IN THE BOLUS HISTORY THAT THE PATIENT COULD NOT REMEMBER GIVING. THE TOTAL DAILY DOSE HISTORY INDICATED THAT THE BASAL AND BOLUS ADDED UP CORRECTLY HOWEVER, THE BASAL TOTALS FOR TWO DAYS WERE .5 UNITS AND .6 UNITS HIGHER THAN THE BASAL PROGRAM INDICATED. THE REPORTER ALSO INDICATED THAT THE PATIENT WAS IN BACK BRACE AND HAD DECREASED ACTIVITY; THE REPORTER ALSO INDICATED THAT THE PATIENT HAD SEVERAL MEDICATIONS AND INCREASED STRESS DUE TO A SURGERY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA REQUIRING MEDICAL INTERVENTION ASSOCIATED WITH QUESTIONED BOLUSES IN THE BOLUS HISTORY AND BASAL TOTALS THAT INDICATED INCREASED INSULIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R