BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3111328 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06335
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS ASSOCIATED WITH THE COMPLAINT OBSERVED IN THE BLACK BOX OR ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND WERE APPROPRIATELY RECORDED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THERE WAS NO DEFECT FOUND ON INVESTIGATION. 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 FOR EVALUATION. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT SHE HAD A HEART ATTACK AND HER BLOOD GLUCOSE (BG) AT 889MG/DL MAY HAVE CAUSED IT. THE PATIENT WAS ADMITTED FROM (B)(6) 2013 TO (B)(6) 2013. THE PATIENT STATED THAT THEY THINK THAT THE PUMP DID NOT MALFUNCTION BUT THE SITE MAY HAVE CAUSED THIS. THE PATIENT STATED THAT SHE HAD A USUAL BLOOD SUGAR AND BOLUSED FOR A MEAL WITHOUT ANY ISSUE. THE PATIENT BEGAN TO GET NAUSEATED AND ENDED UP WITH A HEART ATTACK. THE PATIENT STATED THAT THEY USE CONTACT DETACH INFUSION SET AND DENIED ANY IRRITATION, SWELLING, REDNESS OR INFECTION AT THE SITE. THE PATIENT STATED THAT SHE HAS HAD SITE ISSUES IN THE PAST. THE PATIENT STATED THAT ONE AND A HALF YEARS AGO SHE USED A CANNULA SET BUT WAS ADVISED TO CHANGE TO A NEEDLE SET DUE TO SCAR TISSUE. THE PATIENT CHANGES SITE EVERY TWO TO THREE DAYS. THE PUMP WAS REMOVED UPON ADMISSION AND THE PATIENT WAS STARTED ON AN INSULIN DRIP. THE PATIENT STATED THAT THE HEALTHCARE PROFESSIONAL HAS ADJUSTED RATES INCLUDING COMBO BOLUS DUE TO GASTRO PARESIS. THIS REPORT IS BEING MADE DUE TO HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED WHILE ON PUMP INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213081 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L