BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3061859 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04367
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. A 10U NORMAL BOLUS AND A 10U AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND ACCURATELY RECORDED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE LEVELS UP TO 481 MG/DL WITH POSITIVE URINARY KETONES. THE REPORTER INDICATED THAT THEY HAD LOST FAITH IN THE PUMP BECAUSE THE PATIENT'S BLOOD GLUCOSE LEVELS WERE RUNNING ERRATIC FOR ONE WEEK. THE REPORTER STATED THAT ADJUSTMENTS WERE MADE TO THE PUMP SETTINGS BUT THE PATIENT'S BLOOD GLUCOSE REMAINED ELEVATED. THE REPORTER INDICATED THAT THE ONLY WAY TO DECREASE THE BLOOD GLUCOSE WAS USING INJECTIONS AND THE PATIENT'S BLOOD GLUCOSE WOULD GO BACK UP WHEN ON THE PUMP. THE REPORTER STATED THAT THEY DID NOT FEEL THAT THE PUMP WAS DELIVERING. THE PUMP WAS REVIEW AND CONFIRMED THAT THE PUMP SETTINGS WERE CORRECT, THERE WERE NO ALARMS IN THE PUMP HISTORY, ALL BOLUSES WERE ACCOUNTED FOR, THE TOTAL DAILY DOSE CORRECTLY ADDED, AND THE PRIME HISTORY SHOWED THAT THE SITE WAS BEING REPLACED EVERY 2 DAYS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162749 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening