BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3061256 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04335
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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: A REVIEW OF THE PUMP HISTORY SHOWS THAT THE LAST BASAL AND BOLUS DELIVERIES OCCURRED ON (B)(4) 2013. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT OBSERVED IN THE BLACK BOX OR THE ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE PATIENT REQUESTED TO HAVE SOMEONE CHECK THE PUMP RELATED TO THE EVENT. THE ANIMAS CLINICAL MANAGER MET WITH THE PATIENT AND EVALUATED THE PUMP AND CONFIRMED THAT THE PUMP SETTINGS WERE CORRECT, THE PUMP HISTORIES WERE ACCURATE AND CORRECT, THERE WERE NO RELEVANT ALARMS, THE BASAL AND BOLUS HISTORY WERE CORRECT, AND THE TOTAL DAILY DOSE HISTORY WAS CORRECT. THE CLINICAL MANAGER DETERMINED THAT THERE WAS NO APPARENT ISSUE WITH THE PUMP. THE PATIENT'S HEALTH CARE PROVIDER REQUESTED THAT THE PUMP BE REPLACED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ASSOCIATED WITH AN IMPLIED ALLEGATION OF A PUMP DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162779 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| L