BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4143306 · Received October 6, 2014

    Report

    Report Number
    2531779-2014-28362
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: THE BASAL TOTAL DAILY DOSE HISTORY APPEARED TO BE INACCURATE DUE TO A MANUAL TIME AND DATE CHANGE IN THE BLACK BOX FROM (B)(4) 2014 08:07 TO (B)(4) 2014 08:08 AND THEN FROM (B)(4) 2014 03:44 TO (B)(4) 2014 15:45. THE TOTAL DAILY DOSE SHOWERED TWO RECORDS FOR (B)(4) 2014. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ERRORS, ALARMS OR WARNINGS OCCURRING AT THAT TIME. THERE WAS TYPICAL USAGE ALARMS OBSERVED IN THE ALARM HISTORY. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 398 MG/DL WITH POLYDYPSIA AND POLYURIA ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE INSULIN PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM AND THAT THE DATE WAS INCORRECT IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO THE ALLEGED INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623012 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening