BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3831324 · Received May 24, 2014

    Report

    Report Number
    2531779-2014-14697
    Event Type
    Injury
    Date Received
    May 24, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THERE WERE NO OCCLUSION ALARMS RECORDED IN THE BLACK BOX OR THE HISTORY. THERE WAS NO EVIDENCE OF A HIGH FORCE EVENT RECORDED IN THE BLACK BOX. THE REWIND, LOAD, AND PRIME STEPS WERE SUCCESSFULLY COMPLETED. BOLUSES WERE ATTEMPTED WITH THE TUBING PINCHED OFF AND OCCLUSION ALARMS OCCURRED AFTER THE PUMP ATTEMPTED TO DELIVER. NO OTHER ALARMS OCCURRED DURING THE INVESTIGATION. THE FORCE SENSOR CALIBRATION WAS WITHIN SPECIFICATIONS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS FADED AND PINK. THE BATTERY COMPARTMENT WAS CRACKED IN TWO PLACES, BOTH FROM THE CASE SEAL TO BELOW THE GRIP. THE PUMP WAS OPENED AND REMOVED FROM THE CASE AND NO MOISTURE OR CORROSION WAS OBSERVED IN THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPERGLYCEMIC EVENT ASSOCIATED WITH AN ALLEGED ABSENCE OF AN OCCLUSION ALARM IN THE PUMP. THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE WAS 340 MG/DL WITH SYMPTOMS OF LETHARGY, FREQUENT URINATION, EXTREME DROWSINESS, DIFFICULTY WAKING UP, AND CONFUSION. IT WAS REPORTED THAT THE PATIENT REMAINED ON THE PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. REPORTEDLY, THE PATIENT¿S HEALTHCARE PROVIDER HAD NOT ADJUSTED THE PUMP SETTINGS BEFORE OR AFTER THE EVENT. REVIEW OF THE ALARM HISTORY DETERMINED THAT THERE WAS NO OCCLUSION ALARM AND THE OCCLUSION SENSITIVITY SETTING HAD BEEN SET TO HIGH. AT THE TIME OF THE COMPLAINT, THE PATIENT INSISTED UPON PUMP REPLACEMENT. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPERGLYCEMIA ASSOCIATED WITH ALLEGED ABSENCE OF AN OCCLUSION ALARM IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309683 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening