BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2150077 · Received July 5, 2011

    Report

    Report Number
    2531779-2011-04685
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. THE PUMP ALARM HISTORY REVEALED THREE CS 64 ALARMS AROUND 5:15 AM ON (B)(6) AND TWO OCCLUSION ALARMS AT 8:19 PM ON (B)(6). THE PATIENT REPORTEDLY CLEARED THE ALARMS BY REBOOTING REBOOTED THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE WHEN THE PUMP DISPLAYS A CALL SERVICE (CS) ALARM. IN THIS CASE THE USER DID NOT CALL CUSTOMER SERVICE AT THE TIME THE CS ALARM APPEARED. THE OWNER'S BOOKLET ALSO STATES "TO AVOID THE RISK OF DIABETIC KETOACIDOSIS (DKA) OR VERY HIGH BG, YOU MUST BE PREPARED TO GIVE YOURSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. CALL SERVICE 064 ALARMS WERE OBSERVED IN THE BLACK BOX PRECEDED BY OCCLUSION ALARMS; THE OCCLUSION ALARMS WERE CAUSED BY AN INCREASE IN FORCE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED WITHOUT INTERRUPTIONS AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. AN OCCLUSION WAS INDUCED AND THE PUMP ALARMED APPROPRIATELY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY CHANGED THE INFUSION SET AND CARTRIDGE AND BEGAN TO HAVE OCCLUSION ALARMS AND CS 64 ALARMS DURING NORMAL BASAL DELIVERY. THE PATIENT REPORTS THE PUMP HAS MADE STRANGE MOTOR SOUNDS DURING PRIME BEFORE BUT DOES NOT RECALL IT HAPPENING DURING THE MOST RECENT PRIME PERFORMED THE DAY HE CALLED ANIMAS. HE SAID IT MAY HAVE OCCURRED THE EVENING PRIOR. THE PATIENT EVENTUALLY PRIMED THE PUMP AND STARTED THERAPY. HE SAYS HE REBOOTED THE PUMP WHEN THE CS ALARMS OCCURRED AND CONTINUED TO WEAR THE PUMP DESPITE THE ALARMS. THE PATIENT SAID HE CHECKED FOR KETONES AT 4:30 AM AND THEY WERE NEGATIVE. HE BEGAN TO VOMIT SOMETIME AFTER AND HIS WIFE REPORTEDLY DROVE HIM TO A MINOR INJURY EMERGENCY ROOM WHERE HIS BLOOD GLUCOSE READ "HIGH." THE STAFF AT THAT ER INSTRUCTED HIM TO GO TO A HOSPITAL ER. UPON ADMISSION TO THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 770 MG/DL WITH NAUSEA AND VOMITING. AN HCP AT THE HOSPITAL DIAGNOSED THE PATIENT WITH HYPERGLYCEMIA AND REPORTED THAT THE PATIENT WAS NOT IN DKA. THE PATIENT WAS THEN REMOVED FROM PUMP THERAPY AND PLACED ON AN INSULIN DRIP. THE PATIENT WAS NOT YET DISCHARGED AT THE TIME HE CALLED ANIMAS AND SAID HIS BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS AROUND 400 MG/DL.

    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 48 YR Hospitalization| L| R