BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851631 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14093
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A NORMAL BOLUS AND AN AUDIO BOLUS WERE PERFORMED AND WERE SUCCESSFULLY DELIVERED AND RECORDED IN THE PUMP HISTORY. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING A BLOOD GLUCOSE OF 456 MG/DL WITH SYMPTOMS (UNSPECIFIED). THE PATIENT REPORTED CONSULTING A HEALTH CARE PROFESSIONAL (HCP) WHO REQUESTED THE PUMP BE REPLACED FOR A POTENTIAL MALFUNCTION. DURING TROUBLESHOOTING THE PUMP SETTINGS WERE FOUND TO BE CORRECT, THERE WERE NO RELEVANT ALARMS IN THE HISTORY, AND THE PUMP HISTORY INDICATED NO INTERRUPTIONS OF THE INSULIN DELIVERY. TROUBLESHOOTING OF THE INFUSION SET INDICATED THAT THE PATIENT WAS INCORRECTLY INSERTING THE INFUSION SET BY PLACING THE INSET TUBING INTO THE NOTCH OF THE INSERTER PRIOR TO LOADING THE SPRING. CUSTOMER SUPPORT ADVISED THE PATIENT TO REMOVE THE SITE AND THE CANNULA WAS FOUND TO BE BENT. ANIMAS IS NOT THE LEGAL MANUFACTURER OF THE PATIENT'S INFUSION SET. CUSTOMER SUPPORT ADVISED THE PATIENT THAT REPLACING THE PUMP MAY HAVE NO EFFECT ON THE BLOOD GLUCOSE VALUES IF THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVELS WAS THE INSERTION TECHNIQUE ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING CONSULTATION OF A HEALTH CARE PROFESSIONAL AND BECAUSE OF THE HEALTH CARE PROFESSIONAL'S ALLEGATION OF A POSSIBLE PUMP MALFUNCTION.

    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 75 YR Life Threatening