BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4243428 · Received November 11, 2014

    Report

    Report Number
    2531779-2014-32187
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/30/2015 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTED TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY FEATURES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ERRORS, ALARMS, OR WARNINGS. THE BATTERY AND CARTRIDGE CAPS WERE NOT RETURNED, SO TEST CAPS WERE USED TO COMPLETE TESTING. AN EZBG BOLUS AND AN EZCARB BOLUS WERE MANUALLY CALCULATED AND THE PUMP CORRECTLY CALCULATED THE SAME UNITS. THE PUMP¿S BOLUS CALCULATION FEATURE WAS FOUND TO BE FUNCTIONING PROPERLY. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. 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 600 MG/DL WITH POLYDYPSIA 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 TOTALS MATCHED THE PATIENT¿S PROGRAMMED SETTINGS AND THAT ALL WERE RECORDED AS PROGRAMMED. IT WAS REPORTED THAT THE PATIENT¿S HEALTHCARE PROVIDER MADE RECENT CHANGES TO THEIR BASAL RATE AND BOLUS SETTINGS. ALSO, THE PATIENT USES APIDRA INSULIN AND CTS WAS UNCLEAR IF THEY ARE USING IT CORRECTLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO AN ALLEGED INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726230 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening