BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230997 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11066
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT IDENTIFIED THAT 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 FOR PUMP SERIAL NUMBER (B)(4). THE CORRECT INFORMATION IS THAT ANIMAS HAS NOT CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND HAS NOT CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE CORRECT SERIAL NUMBER FOR THIS PUMP IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS AS FOLLOWS: THE LAST BASAL DELIVERY WAS ON 06/30/2012. THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE OBSERVED; THE TOTAL DAILY DOSES ADDED UP AND EQUALED THE PROGRAMMED BASAL RATE. THE PUMP POWERED ON PROPERLY WITH NO ALARMS, WAS EXERCISED FOR 24 HOURS AND NO ERRORS, ALARMS OR WARNINGS OCCURRED. THE PRODUCT PERFORMED WITHIN SPECIFICATION. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND MOISTURE DAMAGE WAS FOUND ON THE PRINTED CIRCUIT BOARD. 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 USER ALLEGED THAT THE PUMP COULD NOT BE USED, WENT ON A BACKUP PLAN, AND EXPERIENCED AN ADVERSE EVENT WHILE OFF THE PUMP. THEREFORE, THE ADVERSE EVENT WAS DETERMINED TO BE ASSOCIATED WITH USE ERROR. 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. THE DEVICE WAS RETURNED AND EVALUATED ON (B)(4) 2012; A PREVIOUS REPORT WAS SUBMITTED ON (B)(4) 2012 FOR THE ALLEGED KEYPAD ISSUE. TESTING WAS UNABLE TO CONFIRM THE REPORTED UNRESPONSIVE KEYPAD. NO DAMAGE WAS FOUND TO THE KEYPAD AND ALL BUTTONS RESPONDED TO PRESSES APPROPRIATELY. NO OTHER FUNCTIONAL DAMAGE WAS DISCOVERED. THE KEYPAD WAS REMOVED AND NO DAMAGED/MISALIGNED CONTACTS OR CONTAMINATION WERE FOUND UNDER BUTTON CONTACTS. THE CASE WAS FOUND TO BE CRACKED NEAR TO RIGHT CORNER OF DISPLAY AND THE CASE LEAKED DURING TESTING. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON PCB.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS TO COMPLAIN ABOUT THE VACATION PUMP LOANER PROGRAM. DURING THE CONTACT, IT WAS REPORTED THAT IN (B)(6) 2012, THE PATIENT WAS UNABLE TO OBTAIN A LOANER, THE ORIGINAL PUMP WAS UNABLE TO BE USED, AND THE PATIENT EXPERIENCED A SERIOUS BLOOD GLUCOSE EXCURSION WHILE ON A BACKUP PLAN FOR INSULIN DELIVERY. THE PATIENT STATED THAT PUMP SUPPLIES WERE NOT PACKED FOR THE VACATION AND NO ATTEMPT TO OBTAIN SUPPLIES WAS MADE AT THE TIME THE PUMP BECAME UNUSABLE. THE PATIENT REPORTED THAT EVENTUALLY WATER WAS CONSUMED, AN INSULIN INJECTION WAS DELIVERED, AND A VISIT TO THE EMERGENCY ROOM (ER) WAS MADE. IT WAS SAID THAT THE BLOOD GLUCOSE (BG) WAS AROUND 300MG/DL WITH EMESIS AND ¿NEAR SYNCOPAL EPISODE¿ AT THE TIME OF THE ER VISIT. THE PATIENT STATED THAT THE HOSPITAL PERSONNEL WERE UNABLE TO PLACE AN INTRAVENOUS LINE; PATIENT WAS THEREFORE MONITORED BUT NO TREATMENT WAS PROVIDED. THE PATIENT ACKNOWLEDGED THAT A MISTAKE WAS MADE IN THAT PUMP SUPPLIES AND A BACKUP PLAN WERE NOT PREPARED FOR THE VACATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED AN ADVERSE EVENT WHEN THE PUMP COULD NOT BE USED AND AN APPROPRIATE ALTERNATIVE PLAN FOR INSULIN DELIVERY WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331094 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization