BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3903854 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18626
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 23, 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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: TESTING WAS UNABLE TO DUPLICATE COMPLAINT. REVIEW OF TDD HISTORY SHOW DATES GOING FROM (B)(6) 2014 TO (B)(6) 2015 TO (B)(6) 2014.. ON (B)(6) 2014 15:40 PUMP WAS MANUALLY SUSPEND; THEN MANUALLY RESUMED AT 19:46. PUMP WAS THEN POWERED OFF. WHEN PUMP WAS POWERED BACK ON THE TIME/DATE RESET TO THE DEFAULT SETTING. THE TIME/DATE WAS BRIEFLY SET INCORRECTLY TO (B)(6) 2015 02:03. THEN CORRECTED TO (B)(6) 2014 05:36. INSULIN DELIVERIES WERE INTERRUPTED FOR 13HRS 56MINS. PUMP WAS EXERCISED FOR 24HR WITH A 2.0U/HR BASAL RATE; AT END OF 24HR THE TDD HISTORY CORRECTLY REFLECTED 48.0U. PUMP WAS FOUND TO BE DELIVERING WITH RANGE AT CONCLUSION OF DELIVERING ACCURACY TESTING UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED BELOW BUMPER GRIP. RETURNED BATTERY CAP USED TO COMPLETE ALL TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). TREATMENT INCLUDED IV FLUIDS AND INSULIN VIA PUMP. TROUBLESHOOTING WITH CUSTOMER SUPPORT FOUND THE PUMP DATE WAS INCORRECT, BUT THE TIME WAS CORRECT, AND THAT THE PUMP WAS SUSPENDED FROM 3:39 PM TO 7:46 PM ON DAY OF HOSPITALIZATION. PATIENT ADMITTED APPROXIMATELY 8 PM ON (B)(6) 2014. TDD FROM (B)(6) 2014 SHOW SIGNIFICANT DECREASE ON BOTH BASAL AND BOLUS TOTALS. THE BASAL DELIVERY TOTALS IN TDD DO NOT MATCH ACTIVE BASAL PROGRAM TOTAL ¿ NO KNOWN CAUSE FOR VARIATION, BUT THE BASAL HISTORY MATCHES THE ACTIVE BASAL PROGRAM SETTINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCE DKA AND BECAUSE OF THE INACCURACY IN THE BASAL DELIVERY TOTALS IN TDD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380647 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization