BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3030344 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03398
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/08/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED NO EVIDENCE OF LOSS OF PRIME OR LOSS OF CARTRIDGE DETECTION WARNINGS. THE PUMP PRIME HISTORY VERIFIED SMALL PRIME VOLUMES. THE PUMP PERFORMED THE REWIND LOAD, AND PRIME WITHOUT ALARMS. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND THE FORCE SENSOR WAS FOUND TO BE DETECTING THE CORRECT FORCE. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO BE FORCE SENSOR CIRCUIT. 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 REQUESTED FOR RETURN TO ANIMAS AT THIS TIME. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTER INDICATED THAT THE PATIENT WAS NOT WATCHING THE TUBING FOR DROPS DURING PRIME. THE PUMP USER GUIDE INSTRUCTS THE USER TO PRIME THE TUBING UNTIL 5 DROPS ARE SEEN COMING FROM THE END OF THE TUBING. 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 WAS HOSPITALIZED FOR A BLOOD GLUCOSE OVER 600 MG/DL WITH LARGE KETONES. THE REPORTER STATED THAT THE PATIENT WAS RUNNING ELEVATED BLOOD GLUCOSE LEVELS FOR 3 DAYS PRIOR TO ADMISSION. THE REPORTER STATED THAT THE PUMP WAS DISCONTINUED UPON ADMISSION AND THE PATIENT WAS PLACED ON INTRAVENOUS INSULIN. A REVIEW OF THE PUMP HISTORY WITH THE REPORTER CONFIRMED THAT THE TOTAL DAILY DOSE HISTORY CORRECTLY REFLECTED THE BASAL AND BOLUS TOTALS. THE PUMP PRIME HISTORY INDICATED ONLY SMALL PRIME AMOUNTS OF 1.2 UNITS TO 1.9 UNITS. CUSTOMER SUPPORT ADVISED THE REPORTED THAT THE HISTORY INDICATED THAT THE PUMP WAS NOT PRIMED APPROPRIATELY. THE REPORTER INDICATED THAT THE PATIENT WAS NOT PRIMING UNTIL DROPS WERE SEEN COMING FROM THE END OF THE TUBING. ADDITIONALLY THE REPORTER WAS ADVISED THAT THE PRIME HISTORY SHOWED SITES BEING CHANGED OUT ON DAY 4 AND ADVISED THE REPORTED ON THE IMPORTANCE OF USING THE CORRECT FREQUENCY OF SITE ROTATION. THIS REPORT IS MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO INADEQUATE PRIMING OF THE PUMP TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135240 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| L