BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982712 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00661
    Event Type
    Injury
    Date Received
    February 2, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE PUMP'S DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. THE PUMP PASSED A FLOW ACCURACY TEST SET FOR 29 HOURS AT A BASAL RATE OF 2.000U/HR WITH PERCENT ERROR OF -0.12%. NO DEFECTS WERE OBSERVED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS CAUSING HER TO HAVE DEVELOPED HYPERGLYCEMIA. STARTING ON (B)(6) 2011, THE PT INDICATED THAT HER BLOOD GLUCOSE (BG) LEVELS RANGED FROM 300 MG/DL TO "HIGH." SHE ALSO CLAIMED TO HAVE HAD KETONES. THE PT DENIED HAVING AN ILLNESS OR INFECTION. SHE ALSO DENIED HAVING SHORTNESS OF BREATH, NAUSEA, VOMITING, OR PAIN. THE PT ALSO CLAIMED THAT HER BG LEVEL WOULD RISE AND REMAIN ELEVATED WHEN USING THE PUMP. SHE ALSO CLAIMED THAT HER BG'S WOULD RETURN TO TARGET WHEN ADMINISTERING CORRECTIONS VIA SYRINGE. THE PT REPORTEDLY USED DIFFERENT BOTTLES OF INSULIN AND HAD CHANGED THE CARTRIDGE AND INFUSION SET. SHE ALSO HAD ROTATED SITES ON (B)(6) 2011. DURING THAT TIME, THE PT CLAIMED THAT HER BG REMAINED ELEVATED. WHEN THE PT CORRECTED BY SYRINGE, USING SAME BOTTLES OF INSULIN AS USED IN PUMP, SHE CLAIMED THAT HER BG READINGS RETURNED TO TARGET. THE TIME AND DATE ON THE PUMP WERE REPORTEDLY CORRECT. THE BOLUS HISTORY WAS CORRECT. THE PT DENIED ISSUES WITH SITE, SET, OR CARTRIDGE. SHE ALSO DENIED OBSERVING LEAKAGE OR HAVING SCAR TISSUE. NO SUSPENSIONS WERE NOTED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED AN ELEVATED BG LEVEL THAT MEETS ANIMAS' CRITERIA FOR A SERIOUS INJURY AS A RESULT OF USING THE PUMP.

    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 Life Threatening