BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2974781 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02064
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWS THE LAST BASAL AND BOLUS DELIVERIES WERE ON (B)(6) 2013. A ¿REPLACE BATTERY¿ ALARM OCCURRED ON (B)(6) 2013 AT 12:42; THE ALARM WAS CONFIRMED AND DELIVERIES RESUMED THE SAME DAY AT 14:01. A ¿REPLACE CARTRIDGE¿ ALARM OCCURRED ON (B)(6) 2013 AT 16:31; THE ALARM WAS CONFIRMED AND DELIVERIES RESUMED THE SAME DAY AT 18:34. A NORMAL 10UNIT BOLUS AND A 10UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP SUCCESSFULLY COMPLETED AND PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATION. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT SHE HAD BLOOD GLUCOSE (BG) LEVELS UP TO 468 MG/DL WITH LETHARGY, THIRST AND URINATION. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PATIENT STATED THAT THE BOLUS FEATURE OF THE PUMP IS NOT OPERATING. THE PATIENT STATED THAT SHE DID HEAR THE MOTOR RUN BUT DID NOT SEE ANY INSULIN COMING OUT DURING AN AIR BOLUS. THE PATIENT STATED SHE HAD BEEN AS LOW AS 32 MG/DL WHILE USING ALTERNATE INSULIN DELIVERY PLAN. SHE TREATED LOW BG WITH ORANGE JUICE AS ALWAYS. NO TREATMENT ABOVE AND BEYOND USUAL MANAGEMENT WAS REQUIRED. THE PATIENT FELT THAT ISSUE IS RESOLVED AND SHE PLANS TO RETURN CALL TO PROGRAM NEW PUMP WHEN IT ARRIVES TOMORROW AND SHE HAS MORE TIME. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPOGLYCEMIC EVENT WHOLE IN INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78640 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening