BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2810342 · Received October 31, 2012

    Report

    Report Number
    2531779-2012-12974
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/05/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED SEVERAL RECORDS OF AUTO-OFF TIME ALARMS. THE HISTORY INDICATED THAT THERE WERE NO BUTTON PRESSES MADE 12 HOURS PRIOR TO THE ALARM. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE WITH THE AUTO OFF TIME FEATURE SET TO OFF. AT THE CONCLUSION OF THE TESTING, THE PUMP WAS DELIVERY WITH NO ISSUES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON (B)(6) 2012 THE PATIENT WOKE UP WITH THE BLOOD GLUCOSE LEVEL OF 500 MG/DL, AND SHE EXPERIENCED THE SYMPTOMS OF FATIGUE, NAUSEA, THIRST, INCREASED URINATION AND SLEEPINESS. THE PATIENT CORRECTED HER BLOOD GLUCOSE LEVEL USING A DOSE OF INSULIN VIA A SYRINGE INJECTION. THE PATIENT NOTED THE REPORTED PUMP HAD SHUT OFF. A REVIEW OF THE PUMP HISTORY REVEALED THE PUMP GAVE AN AUTO-OFF ALARM ON (B)(6) 2012 AT 10:00 PM. THE PATIENT CLAIMED SHE WAS ASLEEP AND DID NOT HEAR THE ALARM. THE PUMP HISTORY REVEALED THE LAST BUTTON PRESS PRIOR TO THE AUTO-OFF ALARM WAS A BOLUS TAKEN ON (B)(6) 2012 AT 9:05 AM. TROUBLESHOOTING REVEALED THE PUMP AUTO-OFF SETTING WAS SET FOR 12 HOURS, AND THAT THE PUMP HAD POWERED OFF AS PROGRAMMED AFTER 12 HOURS WITHOUT A BUTTON BEING PRESSED. THERE WAS NO EVIDENCE THE PUMP WAS NOT FUNCTIONING APPROPRIATELY. THE PATIENT'S TECHNIQUE WAS INCORRECT BY NOT TAKING A BOLUS OR PRESSING ANY PUMP BUTTON WITHIN THE PROGRAMMED 12-HOUR TIME PERIOD, TO PREVENT THE AUTO-OFF FUNCTION FROM OCCURRING. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA AFTERWARDS, AND RECEIVED TREATMENT WITH INSULIN, THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R