BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172783 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05128
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES.

    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. 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

    THE PATIENT REPORTED HAVING ELEVATED BLOOD GLUCOSE (BG) LEVELS FOR TWO DAYS. HE STATED THAT HIS BG WAS 200 MG/DL TO 300 MG/DL. THERE WERE NO REPORTED SYMPTOMS. THE PATIENT STATED THAT HE WAS CHANGING HIS INSERTION SITE THREE OR MORE TIMES A DAY, AND GIVING MULTIPLE BOLUSES TO TRY AND GET HIS BG DOWN. HE DENIED SEEKING MEDICAL ATTENTION. THE REPORTED BG EXCURSIONS DO NOT MEET THE DEFINITION OF A SERIOUS INJURY. THE PATIENT STATED THAT ALL PUMP SETTINGS WERE CORRECT; ALL CONNECTIONS WERE SECURE AND THERE WERE NO AIR BUBBLES OR LEAKS; AND THERE WERE NO MISSED OR MISTAKENLY CANCELLED BOLUSES. HE REPORTED THAT THERE WERE NO SITE ISSUES AND NO BENT CANNULAS. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND DETERMINED THAT THE BOLUS HISTORY DOES NOT ADD UP WITH THE TOTAL DAILY DOSE HISTORY. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE TROUBLESHOOTING COULD NOT CONFIRM IF THE PUMP WAS DELIVERING INSULIN ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING METER REMOTE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR