BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3240778 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11586
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/28/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT THE LAST BASAL AND BOLUS DELIVERIES OCCURRED ON (B)(6) 2013. THERE WERE NO ALARMS RELATED TO THE COMPLAINT OBSERVED IN THE ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS. NO ALARMS OCCURRED DURING TESTING. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THE FOLLOWING: THE DISPLAY SCREEN WAS DISCOLORED. THE KEYPAD WAS TORN AT THE UP ARROW BUTTON. ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES. WHEN THE KEYPAD COVER WAS REMOVED, THERE WAS EVIDENCE OF CONTAMINATION OBSERVED UNDER THE CONTRAST BUTTON CONTACT. THE AUDIO BOLUS BUTTON COULD NOT BE TESTED, AS THE BOLUS BUTTON COVER WAS MISSING. THE BATTERY COMPARTMENT WAS CRACKED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2013 THE PATIENT WAS HOSPITALIZED WITH ELEVATED BLOOD GLUCOSE (BG). THE REPORTER STATED THAT TWO NIGHTS PRIOR THE PATIENT AWOKE WITH BG OVER 500MG/DL AND VOMITING. THE PATIENT WAS REPORTEDLY REMOVED FROM THE PUMP AND PLACED ON AN INSULIN DRIP AT THE HOSPITAL. WHEN THE PATIENT¿S BG WAS DOWN TO 100MG/DL, THE PATIENT WAS RECONNECTED TO THE PUMP AND BG BEGAN TO RISE AGAIN. THE PATIENT¿S SITE WAS REPORTEDLY CHANGED TWICE. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. THERE WERE NO BOLUSES IN THE HISTORY FOR (B)(6) 2013 DUE TO THE PATIENT BEING IN THE HOSPITAL AND OFF THE PUMP. THE REPORTER NOTED THAT THE PATIENT WAS GOING THROUGH PUBERTY AND GROWTH SPURTS, BUT DENIED ANY CHANGES IN PUMP SETTING, WEIGHT, ACTIVITY, OR MEDICATIONS. THERE WAS NO DEFECT FOUND WITH THE PUMP DURING TROUBLESHOOTING, HOWEVER THE REPORTER WAS NOT CONFIDENT IN THE PUMP DELIVERING INSULIN AND THE PUMP WAS REPLACED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION AND BASED ON THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341255 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R