BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4100942 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26781
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/03/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES INDICATED THAT THE LAST BASAL AND BOLUS DELIVERIES OCCURRED ON (B)(6) 2014. A REVIEW OF THE PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN WAS DISCOLORED. 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. 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT WAS EXPERIENCING LOW BLOOD GLUCOSE (BG) OF 70 MG/DL WITH SEVERE NAUSEA, PERSPIRATION, CONFUSION AND/OR DISORIENTATION, AND INABILITY TO CONCENTRATE AND/OR COGNITIVE IMPAIRMENT. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, AND DID NOT REQUIRE THIRD PARTY ASSISTANCE OR MEDICAL INTERVENTION TO TREAT THE ALLEGED BG EXCURSION. THE REPORTER NOTED THAT THE PATIENT GENERALLY GIVES BOLUS CORRECTIONS USING A SYRINGE DUE TO HAVING TO GIVE VERY LARGE BOLUSES BECAUSE OF INSULIN RESISTANCE. THE REPORTER NOTED THAT THE PATIENT LAST GAVE A SYRINGE BOLUS AT 6:00 PM THE NIGHT PRIOR TO THE ALLEGED BG EXCURSION. THE REPORTER DENIED THAT THE ALLEGED LOW BG WAS RELATED TO THIS BOLUS INJECTION. THE PATIENT REPORTEDLY DISCONTINUED INSULIN PUMP THERAPY AT THE TIME OF THE LOW BG. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. HOWEVER, THE CAUSE OF THE ALLEGED BG EXCURSION COULD NOT BE DETERMINED AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584971 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening