BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3201043 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09476
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/10/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS RELATED TO THE REPORTED COMPLAINT NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE OBSERVED. THE PUMP WAS PROGRAMMED ON A 1.0 UNIT/HOUR BASAL RATE AND EXERCISED FOR 24-HRS; NO UN-PROGRAMMED BOLUSES WERE DELIVERED OR RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. 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. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING TESTING.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER STATED THAT TWO BOLUSES WERE DELIVERED UNINTENTIONALLY. IT WAS SAID THAT THE PATIENT¿S FASTING BLOOD GLUCOSE (BG) WAS 77MG/DL AT 7:47AM WITH AN INSULIN-ON-BOARD READING OF WHAT WAS THOUGHT AT THE TIME TO BE 6.0 UNITS. NO INSULIN WAS DELIVERED AT THAT TIME. AT 9:09 AM THE BG WAS REPORTED TO BE 37MG/DL; NO SYMPTOMS OF HYPOGLYCEMIA WERE REPORTED. THE REPORTER SAID THAT THE PATIENT WAS TREATED WITH ORAL CARBOHYDRATES AND AT 8:41AM WAS 197MG/DL AND BY 10:15AM BG STABILIZED AT 106MG/DL. REVIEW OF THE BOLUS HISTORY SHOWED DELIVERIES AT 8:36AM AND 6:59AM. THE REPORTER CLAIMED THAT THE PATIENT WAS SLEEPING AT 6:59AM AND WAS WITH THE REPORTER AT 8:36AM (NO BOLUS PROGRAMMED OR DELIVERED ACCORDING TO REPORTER). THE KEYPAD WAS SAID TO HAVE BEEN LOCKED WHILE THE PATIENT SLEPT. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION THAT THE PUMP DELIVERED INSULIN WITHOUT USER INTERVENTION AND THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301710 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening