BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1902587 · Received November 12, 2010

    Report

    Report Number
    2531779-2010-02300
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    (B)(4): THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THERE WERE NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. THERE WAS NO DATA AVAILABLE IN THE DOWNLOAD HISTORY OR BLACK BOX FOR THE TIME OF THE REPORTED HIGH BGS ON (B)(4) 2010 DUE TO CONTINUED PATIENT USE OF THE PUMP. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE WAS ADMITTED TO A HOSPITAL FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA. THE PATIENT REPORTEDLY STATED THAT THE PUMP WAS NOT BEING IMPLICATED BUT THE DOCTOR WANTS THE DEVICE TO BE TROUBLESHOOT. THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE LEVELS HAD BEEN ELEVATED FOR THE PAST WEEK. THE PATIENT CLAIMED THAT SHE OBTAINED A "HI" READING ON A GLUCOSE METER. HER USUAL RANGE IS REPORTEDLY IN THE LOW 200'S MG/DL. THE PATIENT STATED THAT SHE CHANGED OUT SITE/SET AND DID NOT RECALL SEEING A BENT CANNULA ALTHOUGH SHE WAS POSITIVE FOR LUMP AT SITE ON ABDOMEN. THE PATIENT WAS ADMITTED TO A HOSPITAL FOR DKA THE DAY PRIOR TO CONTACTING ANIMAS FOR ASSISTANCE. ACCORDING TO THE PATIENT, HER BLOOD GLUCOSE LEVEL UPON ADMISSION WAS 754 MG/DL. THE PUMP WAS DISCONNECTED AND THE PATIENT WAS INITIATED ON IV HYDRATION AND AN IV INSULIN DRIP. AT THE TIME OF THE CONTACT WITH THE ANIMAS REPRESENTATIVE, HER CURRENT BLOOD GLUCOSE LEVEL WAS 123 MG/DL. THE PATIENT WAS INITIATED ON THE PUMP THE DAY SHE CONTACTED ANIMAS. THE PATIENT USES THE INSET 6MM 23 INCH. THE PUMP REPORTEDLY HAD THE CORRECT DATE AND TIME. THE BASAL PROGRAM WAS CORRECT AND ADDING UP CORRECTLY WITH TDD. NO ASSOCIATED ALARMS WERE NOTED IN THE PUMP HISTORY. PRIME HISTORY SHOWED A PRIME TOTAL OF 2.3 UNITS - 6.4 UNITS EVERY 2-3 DAYS. THE PATIENT STATED SHE SAW DROPS FROM END OF TUBING WHEN SHE PRIMED. THE PATIENT IS NOT FILLING THE CANNULA. THE PATIENT PRIMARILY USES HER ABDOMEN AND REPORTED SCAR TISSUE/LUMPS PRESENT. THE PATIENT CLAIMED THAT SHE ROTATES AROUND ABDOMEN. THE ANIMAS REPRESENTATIVE OBSERVED NO ISSUES WITH INSULIN OR AIR BUBBLES. THE PATIENT AND NURSE WERE INSTRUCTED TO DISCUSS POSSIBILITY OF SITE ISSUES. THE PATIENT WAS REFERRED TO A DOCTOR FOR SITE AND SKIN ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R