BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212279 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09911
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/26/2013 WITH THE FOLLOWING FINDINGS: THE REWIND, PRIME AND LOAD STEPS WERE SUCCESSFULLY PERFORMED ON THE PUMP WITH NO STOPPAGE OF THE PISTON ROD. A CARTRIDGE WAS FILLED WITH 100 UNITS AND WAS SUCCESSFULLY DETECTED. A 10 UNIT NORMAL BOLUS AND A 10 UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED ON THE PUMP. THE PUMP CORRECTLY CALCULATED THE REMAINING UNITS AFTER EACH BOLUS. A REVIEW OF THE BLACK BOX REVEALED AN UNCONFIRMED ¿REPLACE CARTRIDGE¿ ALARM ON (B)(6) 2013 AT 5:40AM AND DELIVERY RESUMED ON (B)(6) 2013 8:19AM. A ¿REPLACE CARTRIDGE¿ ALARM WAS REPRODUCED FOR THE INVESTIGATION; THE PUMP GAVE THE APPROPRIATE SOUND AND MESSAGE ON THE SCREEN. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. NO ALARMS OCCURRED DURING TESTING. THE PUMP FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. THE REPORTED INACCURATE REMAINING INSULIN WAS NOT DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. 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

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS AND REPORTED ON (B)(6) 2013, SHE EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 500MG/DL AND WAS HOSPITALIZED. THE PATIENT REPORTEDLY DID NOT HAVE SYMPTOMS. THE PATIENT STATED SHE THOUGHT SHE WAS NOT RECEIVING ANY INSULIN. THE PATIENT REPORTEDLY PERFORMED A TEST BOLUS VIA THE PUMP, NO INSULIN CAME OUT AND THE PUMP INDICATED THAT THE BOLUS DELIVERED. THE PATIENT REPORTEDLY WAS GOING TO BE PUT BACK ON INSULIN PUMP THERAPY WHEN HER BG CAME DOWN TO 120 MG/DL. IT WAS NOTED WITHIN A FEW HOURS THE PATIENT¿S BG ELEVATED TO 350 MG/DL AND THEN THE PATIENT WAS BEING TREATED VIA INSULIN DRIP. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT. CS REPORTEDLY HAD THE PATIENT REMOVE THE CARTRIDGE FROM PUMP AND THE PATIENT OBSERVED THAT CARTRIDGE WAS ALMOST COMPLETELY EMPTY. THERE WAS REPORTEDLY VERY LITTLE INSULIN INSIDE CARTRIDGE. THE CARTRIDGE REPORTEDLY HAD 60 UNITS OF INSULIN LEFT AND THE PUMP¿S HOME SCREEN INDICATED THAT THERE WERE 61 UNITS OF INSULIN REMAINING. THE PATIENT STATED THAT SHE WAS SURE THAT SHE FILLED CARTRIDGE COMPLETELY. THE PATIENT REPORTEDLY COULD SMELL INSULIN BUT HAD DENIED THE CARTRIDGE COMPARTMENT WAS WET. THE PATIENT REPORTEDLY REMAINED IN THE HOSPITAL. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING REASONS: BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND ALSO DUE TO THE ALLEGATION THAT PATIENT CLAIMED THERE WAS MORE INSULIN IN THE CARTRIDGE THAN WHAT WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313466 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L| R