BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2920750 · Received January 17, 2013

    Report

    Report Number
    2531779-2013-00823
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    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

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING : HE WAS RECENTLY DISCHARGED FROM HOSPITAL FOR GASTROPARESIS AND DEHYDRATION, NOT PUMP RELATED. HE STATES AT THAT TIME HIS DOCTOR MADE A CHANGE TO TARGET BLOOD GLUCOSE (BG). PATIENT STATES THAT HE WAS LOW YESTERDAY MORNING AT 50MG/DL WITH MILD SYMPTOMS, TREATED WITH CARBOHYDRATE INTAKE AND BG RESOLVED. HE HAD A LOW TODAY AT 68MG/DL WITH NO SYMPTOMS. PATIENT STATES THAT HE DOESN'T THINK THE IOB IS SHOWING ENOUGH INSULIN STILL WORKING AND IS ALLOWING HIM TO DELIVER TOO MUCH INSULIN. FOR EXAMPLE, THIS MORNING HE GAVE 9.9 UNITS AT 7AM AND AT 948AM THE IOB SHOWED 1.99 UNITS. PATIENT STATES WHEN HE DOES THE MATH TO CALCULATE WHAT IOB SHOULD BE THAT HE SHOULD STILL HAVE HAD ABOUT 3.1 UNITS IOB REMAINING. THE PATIENT CONTINUES ON THE PUMP. CUSTOMER TECHNICAL SUPPORT ADVISED PATIENT TO CONTACT HCP TO SEE IF THEY WOULD LIKE TO MAKE CHANGES TO IOB DURATION, IF IT DOES NOT SEEM TO BE SHOWING ENOUGH IOB REMAINING AFTER 2-3 HOUR THIS BLOOD GLUCOSE EXCURSION IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY EXPERIENCED HYPOGLYCEMIA WITH UNSPECIFIED SYMPTOMS. THERE IS NO INDICATION OF A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26624 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR