BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1971411 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00270
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 11/28/2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE DATA FOR THE TIME OF THE REPORTED HOSPITALIZATION IS NOT AVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE WAS HOSPITALIZED ON (B)(6) 2010, FOR DKA. THE PT CLAIMED THAT FOR THE PAST WEEK, SHE HAD ELEVATED BLOOD GLUCOSE (BG) LEVELS IN THE "300'S" MG/DL. ON (B)(6) 2010, THE PT INDICATED THAT HER BG LEVEL WAS "457 MG/DL" AND SHE HAD SYMPTOMS OF NAUSEA, VOMITING, AND EXTREME FATIGUE. IN THE HOSPITAL, THE PT WAS REPORTEDLY TREATED WITH AN INSULIN DRIP. THE PATIENT WAS REPORTEDLY DISCONNECTED FROM THE PUMP WHILE IN THE EMERGENCY DEPT. THROUGHOUT THE WEEK, THE PT CLAIMED THAT SHE HAD CHANGED HER SITES SEVERAL TIMES DUE TO THE ELEVATED BGS. THE PT CLAIMED THAT THERE IS NOTHING UNUSUAL WITH THE IFS. THE PT INDICATED THAT THE SITES APPEARED HEALTHY AND THERE WAS NO EVIDENCE OF LEAKING OR BLEEDING. THE PT DENIED THAT THERE WAS ANY CHANGE IN ACTIVITY, DIET, OR EXERCISE. THE INSULIN APPEARED TO BE NORMAL AND HAD BEEN OPENED LESS THAN 28 DAYS. THE PT DENIED OBSERVING ANY AIR BUBBLES IN THE CARTRIDGE OR TUBING. THE DATE/TIME AND BASAL RATES OF THE PUMP WERE REPORTEDLY CORRECT. THE BASAL AND BOLUS HISTORY APPEARED TO BE CORRECT. NO ALARMS WERE NOTED FROM THE HISTORY. THE ANIMAS REP INFORMED THE PT THAT THERE WAS NO DEFECT FOUND WITH THE PUMP. ALTHOUGH THERE IS NO EVIDENCE THAT THE PUMP WAS FUNCTIONING IMPROPERLY OR THAT THE DEVICE CONTRIBUTED TO THE PATIENT'S INJURY, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE WAS HOSPITALIZED FOR DKA.

    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 32 YR Hospitalization| L| R