BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2896216 · Received January 4, 2013

    Report

    Report Number
    2531779-2013-00167
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 (B)(6) ON (B)(6) 2012 REGARDING A METER ISSUE AND (B)(6) IN TURN CONTACTED ANIMAS ON (B)(4) 2012 TO RELAY A COMPLAINT REGARDING AN ALLEGED COMMUNICATION FAILURE BETWEEN THE METER REMOTE AND THE INSULIN PUMP. THE REPORTER STATED THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF >500 MG/DL WITH ASSOCIATED NAUSEA, ABDOMINAL PAIN AND THIRST THE MORNING OF AN UNDISCLOSED DATE. THE REPORTER STATED THE PATIENT WAS TAKEN TO THE HEALTHCARE PROVIDER (HCP) FOR EVALUATION. THE PATIENT'S BG WAS REPORTEDLY NOTED TO BE 536 MG/DL AT THE HCP OFFICE. THE REPORTER STATED THE PATIENT RECEIVED A CORRECTION BOLUS AT THE HCP OFFICE, WHICH BROUGHT THE PATIENT'S BG DOWN QUICKLY TO 130 MG/DL. THE REPORTER STATED THE PATIENT REPORTED THAT HE NOTED SEVERAL DAYS PRIOR THAT THERE WAS AN ISSUE WITH THE METER REMOTE SCREEN BEING FUZZY AND THE PATIENT CLAIMED HE WAS NOT ABLE TO READ THE SCREEN INTERMITTENTLY; HOWEVER HE CONTINUED TO USE THE SYSTEM FOR INSULIN DELIVERY. THE NURSE AT THE HCP OFFICE REVIEWED THE PUMP HISTORY AND NOTED THAT NONE OF THE BOLUSES THAT WERE REPORTEDLY GIVEN VIA THE METER REMOTE WERE RECORDED IN THE PUMP HISTORY. THE PUMP'S ALARM HISTORY DID NOT SHOW ANY RECORD OF ALARMS OR ANYTHING ELSE OTHER THAN THE BOLUS HISTORY NOT SHOWING ANY BOLUSES RECORDED FOR THE DATE OF (B)(6) 2012. CUSTOMER TECHNICAL SUPPORT WAS UNABLE TO TROUBLESHOOT THE COMMUNICATION BETWEEN THE METER REMOTE AND THE INSULIN PUMP DUE TO THE UNREADABLE REMOTE SCREEN. TROUBLESHOOTING DID CONFIRM ALL SETTINGS IN THE PUMP WERE SET AS INTENDED AND THERE WAS NO EVIDENCE OF LOSS OF POWER OR INTERRUPTION OF INSULIN DELIVERY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG WHILE USING AN INSULIN PUMP AND METER REMOTE THAT HAD A KNOWN DISPLAY SCREEN PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4916 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Life Threatening| R