BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3202846 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09557
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/18/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. PRIME HISTORY PRIME VOLUMES ASSOCIATED WITH CARTRIDGE CHANGES LESS 2 UNITS. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE AT 5LBS. PUMP PASSED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT. NO BURR WAS OBSERVED ON THE PISTON ROD. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2013, THE REPORTER SAID THAT THE PATIENT¿S BLOOD GLUCOSE (BG) WAS 805MG/DL AT THE HOSPITAL EMERGENCY ROOM (ER); NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA WERE REPORTED AND ALLEGEDLY THE ER PERSONNEL DID NOT TEST FOR KETONES. IT WAS SAID THAT THE PATIENT RECEIVED ONLY INTRAVENOUS SALINE FLUIDS AS TREATMENT IN THE ER. THE PATIENT STATED THAT A BOLUS VIA THE PUMP WAS DELIVERED IN AN AMOUNT THAT EXCEEDED THE RECOMMENDATION OF THE ER NURSE, AND THAT THE BG RESOLVED TO 161MG/DL. THE PATIENT ALLEGED THAT THE PUMP ¿FROZE¿ WHILE IN THE ER AND THAT IT WAS REBOOTED SUCCESSFULLY. THERE WAS NO FURTHER EXPLANATION ABOUT THIS EVENT. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE REPORTER AND FOUND THAT ONLY TWO BOLUSES ON EACH OF 6/5 AND 6/6 WERE RECORDED. THERE WAS NO EVIDENCE THAT BOLUSES WERE CANCELLED. THE PATIENT AND REPORTER DID NOT DENY THAT THE NUMBER OF BOLUSES WAS LIMITED. CTS DETERMINED THAT THE PUMP HAD BEEN SUSPENDED ON MULTIPLE OCCASIONS BETWEEN 6/4 AND 6/6 FOR PERIODS OF TIME RANGING FROM 9 MINUTES TO OVER 4 HOURS. THE PRIME HISTORY REVEALED THAT THE PRIMED INSULIN AMOUNTS APPEARED TO BE INADEQUATE (0.6 UNITS INSTEAD OF 10-12 UNITS) AND INCONSISTENT AMOUNTS TO COMPLETE THE FILL CANNULA STEPS (BETWEEN 0.0 UNITS AND 1.0 UNITS). THE REPORTER AND PATIENT EXPLAINED THAT INSULIN WAS DELIVERED VIA SYRINGES IN ADDITION TO PUMP DELIVERIES. ALTHOUGH SEVERAL DIABETES MANAGEMENT ISSUES MAY HAVE CONTRIBUTED TO THE HYPERGLYCEMIC EVENT, USE OF THE INSULIN PUMP CANNOT BE RULED OUT AS ANOTHER CONTRIBUTOR TO THE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE POSSIBILITY THAT USE ERROR AND/OR DEVICE ISSUE CONTRIBUTED TO THE PATIENT¿S HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302519 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization