BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213775 · Received August 17, 2011

    Report

    Report Number
    2531779-2011-05961
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 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 TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS NOT DUPLICATED DURING TESTING. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE COMPLETED A CARTRIDGE CHANGE WHILE ATTACHED, AND THE PUMP DISPENSED INSULIN DURING THE LOAD STEP. SHE STATED THAT SHE EXPERIENCED A BLOOD GLUCOSE (BG) OF 48 MG/DL AS A RESULT, AND WAS TREATED AT HOME WITH FOOD AND SODA FOR TWO HOURS UNTIL HER BG RESOLVED TO TARGET RANGE. A FAMILY MEMBER WAS ON THE PHONE WITH CUSTOMER SUPPORT ALONG WITH THE PATIENT, AND CONFIRMED THE INCIDENT. CUSTOMER SUPPORT (CS) ADVISED THE PATIENT TO NEVER PERFORM A CARTRIDGE CHANGE WHILE ATTACHED. THE PATIENT'S BG AT THE TIME OF THE CALL TO CS WAS REPORTEDLY WITHIN TARGET RANGE. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE REPORTED INCIDENT.

    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 17 YR