BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2860752 · Received December 6, 2012

    Report

    Report Number
    2531779-2012-14277
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. BLACK BOX REVEALS 164 WARNING "NO DELIVERY, INSULIN LEVEL TO LOW TO MAKE TARGET DELIVERY" ON (B)(6) 2012 8:11PM ONLY 1 UNIT OF INSULIN REMAINING AT TIME OF ATTEMPTED 3.5UNIT BOLUS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS OR WARNINGS AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. PUMP WAS PRIMED UNTIL 5 UNITS REMAINED; A NORMAL 10 UNIT BOLUS WAS ATTEMPTED. PUMP GIVES APPROPRIATE "DELIVERY CANCELED DUE TO LOW CARTRIDGE" WARNING.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CALLED ANIMAS AND ALLEGED THE FOLLOWING: THE PUMP IS NOT DELIVERING INSULIN CORRECTLY. THE PATIENT HAS BEEN USING HER PUMP TO DELIVER HER BASAL RATE, AND GIVES INJECTIONS TO KEEP HER BLOOD GLUCOSE(BG) IN NORMAL RANGE, DUE TO THE ALLEGED PUMP MALFUNCTION. AT TIME OF THIS CALL BG WAS 130MG/DL. REPORTEDLY HER BG HAS BEEN AS LOW AS 42MG/DL AND AS HIGH AS THE 400'S MG/DL. WITH THE LOW BG SHE HAS SYMPTOMS OF HOT SWEATS, HEART PALPITATIONS, HARD TO CONCENTRATE, WEAKNESS. ON (B)(6) 2012, SHE HAD TO BE GIVEN GLUCAGON TO BRING SUGAR BACK UP. SHE HAD TREATED A HIGH BG WITH AN INSULIN INJECTION, AND NOTICED HER BG DROPPED FAST FROM 250 TO 55 TO 42 MG/DL WITHIN 40 MINUTES. PATIENT STATES THAT HER BG HAS BEEN UP AND DOWN DUE TO THE PUMP ISSUE. CUSTOMER SUPPORT REVIEWED AND THE DELIVERY STEP IS NORMAL. IN THE ALARM HISTORY, NOTED ONLY LOW CARTRIDGE, EMPTY CARTRIDGE, AND BATTERY ALARMS. THE PATIENT DENIES ANY TRAUMA OR MOISTURE TO THE PUMP AND REPORTEDLY IS NOT ABLE TO DELIVER MORE THAN 3.00 UNITS OF INSULIN OR THE PUMPS MOTOR MAKES A LOUDER GRINDING NOISE, SO SHE HAS BEEN GIVING AN INJECTION FOR HER BOLUS AND USES THE PUMP TO RECEIVE HER BASAL RATE. PATIENT STATES THAT HER HEALTH CARE PROFESSIONAL (HCP) NEEDS TO MAKE CHANGES TO HER BASAL SETTINGS IN HER PUMP AND REFUSES TO CHANGE THE SETTINGS UNTIL THE PUMP WAS REPLACED DUE TO A MOTOR SOUND ISSUE . ALSO THE PATIENT MAY NOT BE GIVING ACCURATE AMOUNTS OF INJECTIONS DUE TO A METER ISSUE, INACCURATE READINGS. THE PATIENT HAS RESUMED USE OF THE PUMP AT THIS TIME, AND WAS ADVISED TO MONITOR HER BG AND CALL HER HCP IS SHE CONTINUES TO HAVE ISSUES WITH BG. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THE PUMP IS NOT DELIVERING INSULIN PROPERLY, AND THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPOGLYCEMIA.

    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 57 YR Life Threatening