BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4102785 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26849
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    September 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND THAT THE TIME AND DATE WAS SET INCORRECTLY ON THE COMPLAINT DATE AFTER THE PUMP WAS POWERED OFF FOR AN UNDETERMINED TIME PERIOD. THE TIME AND DATE WAS RESET MANUALLY ON THE DATE OF THE COMPLAINT. THE TOTAL DAILY DELIVERY APPEARED TO BE INCORRECT DUE TO THE INCONSISTENT TIME/DATE RESET ISSUE. THE CAPS WERE RETURNED AND USED IN THE EVALUATION. THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE FORCE SENSOR CALIBRATION READING AND THE PUMP DELIVERY ACCURACY WERE WITHIN SPECIFICATIONS. BOLUS EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE REPORTED LOSS OF PRIME ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATE DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PATIENT HAD EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON PUMP THERAPY. REPORTEDLY, ON AN UNSPECIFIED DATE, THE PATIENT¿S BLOOD GLUCOSE (BG) WAS AT 600 MG/DL WITH ABDOMINAL PAIN AND VOMITING. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVED ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT AND THE PATIENT ALLEGEDLY REMAINED ON PUMP THERAPY WITHOUT ANY RECENT ADJUSTMENT TO THE PUMP SETTINGS. CUSTOMER SUPPORT AGENT REVIEWED THE EVENT WITH THE REPORTER. REVIEW OF POTENTIAL CAUSES FOR INACCURATE DELIVERY DETERMINED THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. IT WAS ALSO DETERMINED THAT THE EVENT WAS NOT RELATED TO A TIME/DATE ISSUE SINCE THE PATIENT ONLY HAD ONE BASAL SETTING. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE REPORTED HISTORY SETTINGS ISSUE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA ASSOCIATED WITH A HISTORY SETTINGS ISSUE OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584606 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening