BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222430 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10404
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    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 CONTACTED ANIMAS STATING THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 549 MG/DL WITH LARGE KETONES. THE PATIENT REPORTEDLY FELT NAUSEATED, WAS VOMITING, FELT DIZZY, HAD A HEADACHE AND WAS HOSPITALIZED. UPON ADMISSION AT THE HOSPITAL, THE PATIENT REPORTEDLY WAS DISCONNECTED FROM THE PUMP AND WAS TREATED VIA INTRAVENOUS FLUIDS AND INSULIN. THE REPORTER STATED AFTER REPLACING THE BATTERY IN RESPONSE TO A ¿REPLACE BATTERY¿ ALARM EMITTED BY THE PUMP, SHE TRIED TO PRIME THE PUMP AND PERFORM AN AIR BOLUS AND THE REPORTER CLAIMED SHE DID NOT SEE ANY INSULIN COME OUT OF THE TUBING. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY; HISTORY INDICTED THE FOLLOWING: AN ¿EMPTY CARTRIDGE¿ ALARM ON (B)(6) 2013 AT 3:47 AM; FOLLOWED BY AN ¿EMPTY CARTRIDGE¿, THE PUMP WAS NOT PRIMED UNTIL (B)(6) 2013 AT 11:02 PM. THE REPORTER STATED THAT THE CARTRIDGE WAS REPLACED AFTER RECEIVING THE ¿EMPTY CARTRIDGE¿ ALARM. ADDITIONAL PUMP HISTORY INDICATED THAT THE TOTAL DAILY DOSE FOR BASAL DELIVERY ON (B)(6) 2013 WAS 41.84 UNITS, A NORMAL 2 HOUR BASAL DELIVERY WAS 64.80 UNITS AND THE PATIENT PROGRAMMED ONE BOLUS ON (B)(6) 2013 AT 6:41 AM. THE PUMP ALARM HISTORY INDICATED THE FOLLOWING ON (B)(6) 2013: A ¿REPLACE BATTERY¿ ALARM AT 10:44 PM AND A ¿OCCLUSION¿ ALARM AT 11:07 PM. DURING A REVIEW OF THE PUMP BOLUS HISTORY; IT WAS NOTED ONE BOLUS WAS PERFORMED AT 6:41 AM ON (B)(4) 2013 AND NO BOLUSES WERE PROGRAMMED ON (B)(6) 2013. THERE WAS NO INDICATION OF A PUMP MALFUNCTION AFTER TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BECAUSE THE PUMP REPORTEDLY WAS NOT PRIMED UNTIL (B)(6) 2013, MULTIPLE BOLUSES WERE NOT PERFORMED AND THE PATIENT MAY NOT HAVE BEEN ADDRESSING ALARMS APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324270 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R