BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3082144 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05463
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    March 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/04/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA BEGAN ON (B)(4) 2015. THE DATA FROM THE TIME OF THE ALLEGED INCIDENT WAS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE CURRENT PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. A REVIEW OF THE CURRENT TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY WAS DISCOLORED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT HE HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) UP TO 511MG/DL WITH SWEATING AND EXCESSIVE THIRST. THE PATIENT REPORTEDLY CHANGED HIS SITE THE PREVIOUS NIGHT BEFORE GOING TO BED AND AWOKE WITH A BG OF 400MG/DL. THE PATIENT STATED THAT HIS BGS WERE NOT RESPONDING TO BOLUSES VIA THE PUMP, SO HE TREATED THE BG EXCURSIONS WITH INSULIN INJECTIONS. THE PATIENT CHANGED THE SITE AGAIN WHILE ON THE CALL WITH ANIMAS, AND NO SITE OR SET ISSUES WERE NOTED. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. CTS ADVISED THE PATIENT THAT TROUBLESHOOTING DID NOT INDICATE ANY ISSUES WITH THE INFUSION SET OR THE PUMP. THE PATIENT WAS ADVISED TO CONTACT HIS HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING THE REPORTED BG ELEVATIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185484 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening