BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3092407 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05867
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 [DATE OF SUBMISSION (B)(4) 2013]-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS ABLE TO POWER ON PROPERLY AND WAS EXERCISED FOR 24 HOURS WITH NO CALL SERVICE ALARMS OR POWER ISSUES. THE PUMP WAS OPENED AND NO ISSUES WERE FOUND. THE PUMP HISTORY WAS REVIEWED AND THERE WAS INDICATION OF CALL SERVICE ALARMS FOLLOWED BY REBOOTING OF THE PUMP BY THE USER ON (B)(4) 2013. THE PUMP HISTORY SHOWED THAT THE USER DID NOT CLEAR THE ALARM FOR HOURS AFTER THE ALARM BEGAN. NO PUMP ISSUES WERE FOUND. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, STATING THAT THE PATIENT EXPERIENCED ERRATIC BLOOD GLUCOSE LEVELS UP TO 600 MG/DL WITH SEVERE NAUSEA AND LEG PAIN. THE REPORTER STATED THAT THE PATIENT RECEIVED CALL SERVICE 088 ALARMS BUT THE PATIENT DID NOT KNOW TO REBOOT THE PUMP. THE PATIENT REPORTEDLY DISCONTINUED THE PUMP IN FAVOR OF USING INSULIN INJECTIONS. THE REPORTER INDICATED THAT THE PATIENT DID NOT HAVE INSTRUCTIONS FROM A HEALTH CARE PROVIDER FOR USING SYRINGES AS AN ALTERNATE TREATMENT METHOD. THE REPORTER WAS WALKED THROUGH THE PROCESS OF REBOOTING THE PUMP TO CLEAR THE ALARM AND THE PATIENT WAS ABLE TO RECONNECT AND RESUME TREATMENT USING INSULIN PUMP THERAPY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING A BACKUP TREATMENT PLAN DUE TO NOT CLEARING AN ALARM ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195246 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening