BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221198 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31250
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/16/2014 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE REPORTED INACCURATE DELIVERY ISSUE WAS NOT VERIFIED IN THE BLACK BOX OR DUPLICATED IN THE EVALUATION. REVIEW OF BLACK BOX DATA FOUND THAT THREE DAYS BEFORE THE COMPLAINT DATE, DELIVERY WAS MANUALLY SUSPENDED AND RESUMED ONCE, THEN SUSPENDED AGAIN AND NOT RESUMED UNTIL THREE DAYS LATER ON THE COMPLAINT DATE. THE TOTAL DAILY DELIVERIES CORRECTLY REFLECTED USER¿S PROGRAMMED BASAL SETTING. REVIEW OF ALARM HISTORY DID NOT FIND ANY UNUSUAL ACTIVITIES. USING THE RETURNED CAPS, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. BOLUS DELIVERY EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. PUMP DELIVERY ACCURACY WAS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON PUMP THERAPY. REPORTEDLY, ON (B)(6) 2014, THE PATIENT¿S BLOOD GLUCOSE (BG) READING WAS AT 738 MG/DL WITH NAUSEA, VOMITING, AND SYMPTOM OF DIABETIC KETOACIDOSIS. IT WAS REPORTED THAT THE PATIENT WAS TREATED BY MEDICAL PERSONNEL AT THE HOSPITAL WITH UNSPECIFIED TREATMENTS. THE PATIENT ALLEGEDLY REMAINED HOSPITALIZED AT THE TIME OF THE CALL AND NO RECENT ADJUSTMENTS TO THE PUMP SETTINGS WAS REPORTED. CUSTOMER TECHNICAL SUPPORT AGENT REVIEWED THE POTENTIAL CAUSES FOR INACCURATE DELIVERY AND DETERMINED THAT ALL BASAL AND BOLUS DELIVERIES WERE CORRECT AND AS PROGRAMMED. REVIEW OF POTENTIAL CAUSES FOR BG ISSUE AND POTENTIAL CAUSES FOR PERCEIVED INACCURATE DELIVERY DID NOT ASCERTAIN ANY SPECIFIC CAUSES FOR THE REPORTED BG EXCURSION. THE REPORTED INACCURATE DELIVERY ISSUE WAS NOT RESOLVED WITH TROUBLE SHOOTING. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT REQUIRING HOSPITALIZATION RELATED TO AN ALLEGED INACCURATE DELIVERY ISSUE WITH THE PUMP OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702723 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R