BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3954970 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21259
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4)2014 WITH THE FOLLOWING FINDINGS: THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. THE LAST BASAL DELIVERY AND BOLUS WERE ON (B)(4) 2014. THE TOTAL DAILY DOSE (TDD) HISTORY SHOWED THE PUMP WAS RUNNING ON THE YEAR 2007 SINCE 06/01. THE BASAL TDD HISTORY APPEARED TO BE INACCURATE DUE TO INCONSISTENT TIME AND DATE; THE DATE VARIED FROM (B)(4)2007 TO (B)(4)2014. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 2.0 UNIT/HR BASAL RATE AND AT THE END THE TDD BASAL HISTORY CORRECTLY SHOWED 48.0 UNITS. THERE WERE NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE IN THE ALARM HISTORY. THE TDD¿S ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. THE PUMP SUCCESSFULLY COMPLETED A DELIVERY ACCURACY TEST. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN HAD A DISCOLORED CONTRAST. ALSO UNRELATED, THERE WAS DAMAGE TO THE PUMP CASE BETWEEN THE DISPLAY LENS AND CASE SEAL. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(4) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 465 MG/DL WITH THE FOLLOWING SYMPTOMS: POLYDYPSIA, POLYURIA, BLURRED VISION, CHEST PAIN, IRRITATION, AND RAPID, DEEP BREATHING/ SHORTNESS OF BREATH. 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 DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID NOT MATCH THE ACTIVE BASAL PROGRAM DUE TO THE BASAL EDIT SCREEN BEING ACCESSED AND THE PUMP DELIVERING A BASAL RATE OF ZERO. ALSO DURING TROUBLESHOOTING WITH CTS, IT WAS CONFIRMED THAT THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS, AND THE BOLUS TOTALS MATCHED AND WERE ALL RECORDED AS PROGRAMMED. THE PATIENT WAS ABLE TO DELIVER ONE UNIT VIA AIR BOLUS WHILE ON THE PHONE WITH CTS AND IT DID RECORD CORRECTLY IN THE PUMP¿S HISTORY. IT WAS REPORTED THAT THE PATIENT HAD STARTED ON SYNTHROID 25 MCG DAILY LAST WEEK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO THE TOTAL DAILY DOSE OF THE BASAL RATE NOT MATCHING THEIR ACTIVE BASAL PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433900 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening