BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2317854 · Received November 1, 2011

    Report

    Report Number
    2531779-2011-08121
    Event Type
    Injury
    Date Received
    November 1, 2011
    Report Date
    October 11, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 11/29/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS:AN EZPRIME OPERATION WAS PERFORMED WITH NO ISSUES. THE PUMP PASSED THE FORCE SENSOR CALIBRATION TEST. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THE BLACK BOX SHOWED MULTIPLE LOSS OF PRIME WARNINGS, ONE OF WHICH WAS UNACKNOWLEDGED FOR TWO HOURS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED WITHOUT INTERRUPTIONS AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS OPEND AND THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED; 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 506MG/DL WITHOUT SYMPTOMS OF HYPERGLYCEMIA. THE REPORTER INDICATED THAT THE PUMP EMITTED 3 LOSS OF PRIME WARNINGS EARLIER IN THE MORNING, BUT WAS UNABLE TO DETERMINE HOW LONG THE PATIENT WAS WITHOUT INSULIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening