BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2924520 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-00939
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE IOB FEATURE WAS OBSERVED TO BE ON DURING A REVIEW OF THE PUMP HISTORY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. THE PUMP SUCCESSFULLY POWERED ON WITH NO PRIME ISSUES NOTED. A "NORMAL", "EZ-CARB", "EZ-BG" AND "COMBO" BOLUSES WERE SUCCESSFULLY PERFORMED AND ACCURATELY RECORDED IN PUMP HISTORY WITH THE CORRECT TIME AND ORDER. A 5 UNIT BOLUS WAS PERFORMED; THE PUMP DISPLAYED THE CORRECT IOB UNIT AMOUNT. THE PUMP WAS OPENED AND NO MOISTURE INGRESS OR INTERMITTENT ISSUES WERE FOUND WITH PCB OR TO THE FLEX. THERE WERE NO ISSUES FOUND WITH THE IOB DURING INVESTIGATION. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING LOW BLOOD GLUCOSE LEVELS OF 2.2 MMOL/L AND 2.5 MMOL/L AT LUNCH TIME RELATED TO A SUSPECTED ISSUE WITH THE INSULIN ON BOARD (IOB) FEATURE OF THE PUMP. THE PATIENT REPORTED THAT THE IOB APPEARED TO BE MISCALCULATING RESULTING IN BOLUS CALCULATIONS AND DELIVERIES THAT WERE TOO LARGE. A REVIEW OF THE BOLUS HISTORY INDICATED THAT HE PATIENT BOLUSED 0.8 UNITS AT 11:38 AM, 7.1 UNITS AT 12:14 PM, AND AT 1:33 PM THE PUMP IOB WAS READING 4.77 UNITS. THE PATIENT REPORTED FEELING THAT THE IOB READING SEEMED EXTREME AND CONTACTED ANIMAS FOR ASSISTANCE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA RELATED TO A POTENTIAL BOLUS CALCULATION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30531 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening