BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3061606 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04354
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WERE NO ERRORS OR ALARMS IN THE HISTORY RELATED TO THE COMPLAINT. THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. THE BOLUS HISTORY INDICATED A 12.00U BOLUS WAS GIVEN ON (B)(4) 2013 AT 11:06. A TEST WAS PERFORMED WITH 7.25U BOLUS AND AN INSULIN ON BOARD (IOB) DURATION PERIOD OF 2.0 HOURS. AFTER THE 2 HOURS THE IOB STATUS WAS 0.00 AND THIS WAS ACCURATELY REFLECTED IN THE IOB STATUS; THE IOB WAS FOUND TO FUNCTIONING PROPERLY. A 10U NORMAL BOLUS AND A 10U AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND ACCURATELY RECORDED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    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.

    Description of Event or Problem · 1

    THE REPORTER AND PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING AN EVENT IN WHICH THE PATIENT REPORTED THAT THE PUMP DELIVERED TOO MUCH INSULIN. THE PATIENT INDICATED THAT THE PUMP WAS PROGRAMMED FOR A BOLUS FOR BREAKFAST BUT THE PUMP DELIVERED A SECOND BOLUS. THE PATIENT REPORTEDLY WENT TO THE HOSPITAL WITH A BLOOD GLUCOSE OF 48 MG/DL TO FIND OUT WHAT WAS GOING ON. THE PATIENT REPORTED THAT THE INSULIN ON BOARD (IOB) FEATURE SHOWED 9.25 UNITS OF INSULIN PRIOR TO LUNCH HOWEVER THE BOLUS WITH BREAKFAST WAS ONLY FOR 7.25 UNITS. THE PUMP SETTINGS WERE REVIEWED AND CONFIRMED THAT THE PUMP SETTINGS WERE CORRECT. THE PUMP HISTORY WAS REVIEWED AND CONFIRMED NO ALARMS, NO CANCELLED BOLUSES, ALL BOLUS WERE ACCOUNTED FOR, THE BASAL HISTORY WAS CORRECT, AND THE TOTAL DAILY DOSE HISTORY WAS CONFIRMED TO BE ACCURATE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT SOUGHT MEDICAL ATTENTION FOR HYPOGLYCEMIA RELATED TO AN ALLEGATION OF A PUMP OVER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162808 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening