BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3943353 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20556
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. NO ABNORMAL PUMP FUNCTION WAS OBSERVED IN THE BLACK BOX. THE TOTAL DAILY DOSE HISTORY APPROPRIATELY REFLECTED THE USER PROGRAMMED BASAL RATES AND BOLUS DELIVERIES. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERY, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP CORRECTLY CALCULATED BOLUSES AND PASSED A DELIVERY ACCURACY TEST. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT CRACK WAS DISCOVERED. THE RETURNED BATTERY CAP WAS ABLE TO PROPERLY SECURE TO THE PUMP.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE WAS 30 MG/DL WITH CONFUSION AND DISORIENTATION. IT WAS REPORTED THE PATIENT REQUIRED ASSISTANCE FROM A THIRD PARTY. THE REPORTER STATED THE BASAL AND BOLUS HISTORIES CORRELATED TO THE BASAL AND BOLUS TOTAL RECORDED IN THE TOTAL DAILY DOSE HISTORY. REPORTEDLY, BOLUSES WERE RECORDED APPROPRIATELY IN THE BOLUS HISTORY. IT WAS REPORTED THAT DURING TROUBLESHOOTING WITH ANIMAS CUSTOMER TECHNICAL SERVICES, THE PUMP DELIVERED AN AIR BOLUS THAT WAS RECORDED APPROPRIATELY IN THE PUMP¿S BOLUS HISTORY. IT WAS REPORTED THERE WAS AN INCORRECT MANUAL CALCULATION OF BASAL DOSAGE. ANIMAS CUSTOMER TECHNICAL SERVICES DETERMINED A CHANGE IN PHYSICAL ACTIVITY LEVEL WITHOUT ADJUSTMENTS TO INSULIN REGIMEN, DEHYDRATION, AND A RECENT SEVERE HYPOGLYCEMIA CONTRIBUTED TO THE REPORTED HYPOGLYCEMIA. IT WAS REPORTED THE PUMP¿S SETTINGS WERE NOT RECENTLY CHANGED AND THE PATIENT DID NOT RECEIVE TREATMENT OUTSIDE OF ROUTINE DIABETES MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED HYPOGLYCEMIA WAS ATTRIBUTED TO A USE ERROR. THERE WAS NO INDICATION OR ALLEGATION OF A MALFUNCTION OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423174 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Life Threatening| R