BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2973485 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02011
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. THE TOTAL DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DIE TO TIME AND DATE RESET. PUMP POWERS ON WITH THE DISPLAY REMAINING BLANK. PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE DISPLAY SCREEN. WHEN A TEST DISPLAY SCREEN WAS USED THE DISPLAY FUNCTIONED PROPERLY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE BOLUS BUTTON IS MISSING.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE DISPLAY ON THE PUMP WENT BLACK YESTERDAY. THE REPORTER STATED THAT SHE INSERTED A NEW BATTERY AND THE DISPLAY WAS STILL BLACK. SHE TRIED SEVERAL DIFFERENT BATTERIES. THE REPORTER DENIED TRAUMA OR MOISTURE TO THE PUMP. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL AT THE TIME OF THE CALL WAS 331MG/DL WITH KETONES. THE REPORTER STATED THAT THEY WILL BE CONTACTING THE HEALTHCARE PROFESSIONAL TO ADDRESS THE HIGH BG. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT DUE TO ALLEGED BLACK DISPLAY SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78226 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening