BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3772261 · Received April 25, 2014

    Report

    Report Number
    2531779-2014-11370
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/19/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR IN THE DOWNLOAD HISTORY. VISUAL INSPECTION CONFIRMED THAT THE KEYPAD HAD PEELED OFF THE PUMP AND ALL BUTTON CONTACTS WERE MISSING. ALL KEYPAD BUTTONS WERE SUBSEQUENTLY UNRESPONSIVE. ADDITIONAL TESTING COULD NOT BE COMPLETED DUE TO THE UNRESPONSIVE BUTTONS. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT¿S KEYPAD BUTTONS BECAME UNRESPONSIVE AND THE PATIENT CAME OFF THE PUMP WITHOUT A BACK-UP PLAN FOR INSULIN DELIVERY. THE REPORTER STATED THAT THE PATIENT SUBSEQUENTLY EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) UP TO 500 MG/DL AND WAS TREATED IN THE HOSPITAL. THE REPORTER NOTED THAT THE PATIENT EXPERIENCED MODERATE KETONES AND THE FOLLOWING SYMPTOMS: VOMITING, SEVERE WEAKNESS, RAPID BREATHING/SHORTNESS OF BREATH/CHEST PAIN, EXTREME THIRST, NAUSEA, AND SYMPTOMS OF DEHYDRATION. THE PATIENT WAS REPORTEDLY REMOVED FROM THE PUMP AT THE HOSPITAL AND WAS TREATED WITH INSULIN INJECTIONS AND IV FLUIDS. REPORTEDLY, THE KEYPAD COVER HAD BECOME DAMAGED AND WAS MISSING AND/OR PEELING. SUBSEQUENT TO THE KEYPAD DAMAGE, ALL THE KEYPAD BUTTONS REPORTEDLY BECAME UNRESPONSIVE, AND THE PATIENT DID NOT USE AN ALTERNATE PLAN OF INSULIN DELIVERY. THE PATIENT WAS REPORTEDLY WITHOUT INSULIN FOR TWO DAYS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA RELATED TO AN INADEQUATE BACK-UP PLAN. AN ALLEGED PUMP MALFUNCTION WAS IDENTIFIED AS THE REASON FOR THE PATIENT NOT CONTINUING WITH INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251941 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R