BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2830086 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13500
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DUE TO CONTINUED USE OF THE PUMP, THE EVENT DATE WAS OVERWRITTEN IN THE PUMP¿S HISTORY. REVIEW OF THE PUMP¿S HISTORY SHOWED NO ALARMS OR ERRORS RELATED TO THE EVENT AND ONLY TYPICAL USAGE WAS OBSERVED. THE CURRENT TOTAL DAILY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER SON (THE PATIENT) AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE REPORTER ALLEGED THAT POSSIBLY THE PUMP WAS NOT DELIVERING INSULIN ACCURATELY. THE REPORTER STATED THAT THE PATIENT HAD RECEIVED 20 UNITS OF INSULIN THE MORNING OF (B)(6) 2012, AT 7:00 AM. THE PATIENT THEN REPORTEDLY STARTED PUMP THERAPY AT 3:00 PM THAT SAME DAY. DUE TO RECEIVING THE LANTUS INSULIN EARLIER IN THE DAY, THE PATIENT'S DOCTOR INSTRUCTED HIM TO START ON A TEMP BASAL OF "-90%." THE REPORTER REQUESTED FOR ASSISTANCE WITH STARTING THE WEEKDAY BASAL PROGRAM. THE REPORTER MENTIONED THAT THE PATIENT HAD A BG LEVEL OF "323 MG/DL" AND WAS SPILLING KETONES. THE REPORTER DENIED THAT THE PATIENT HAD ANY SYMPTOMS. THE ANM REPRESENTATIVE INVOLVED IN THIS CONTACT ADVISED THE REPORTER TO KEEP THE PATIENT WELL HYDRATED AND TO MONITOR HIS BG LEVELS. THE REPORTER MENTIONED THAT THE CDE ORDERED FOR THE REGULAR BASAL PROGRAM TO START AT 7:00 PM THAT SAME DAY. NO MEDICAL INTERVENTION WAS REPORTED BY THE PATIENT'S MOTHER. THE PUMP'S DATE AND TIME WERE CONFIRMED AS BEING CORRECT. THE PUMP'S BASAL SEGMENTS WERE PROGRAMMED AS DESIRED. THE PUMP'S HISTORIES WERE REVIEWED AND CONFIRMED AS BEING CORRECT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED AN ELEVATED BG LEVEL WITH KETONES. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE PUMP CONTRIBUTED TO THE PATIENT'S ELEVATED BG LEVELS CONSIDERING NO ISSUES WERE FOUND WITH TROUBLESHOOTING OF THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening