BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2831671 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13587
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/09/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. INFORMATION FROM THE REPORTED EVENT DATE IS OVERWRITTEN IN THE BLACK BOX AND THE HISTORY, AVAILABLE DATA SHOWS NO ACTIVITY OUTSIDE OF NORMAL USE. TDD ADD UP CORRECTLY AND REFLECT THE PROGRAMMED BASAL TARGET. PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. PUMP WAS ABLE TO PASS ¿EZ-PRIME¿ STEPS AND TO EXERCISE FOR 24H, NO ALARMS OCCURRED DURING THE DURATION TEST.3-FORCE SENSOR CALIBRATION READING IS WITHIN SPECIFICATION. THE PUMP PASSED A 29H FLOW ACCURACY TEST SUCCESSFULLY. AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER CONTACTED ANIMAS TO REPORT A LOW BLOOD GLUCOSE (BG) EXCURSION. THE REPORTER STATED THAT THE PATIENT HAD A LOW BG OF 33 MG/DL EARLIER THAT DAY. IN RESPONSE TO THE LOW SHE HAVE THE PATIENT CANDY AND REPORTED THAT HIS CURRENT BG WAS 140 MG/DL AND THE PATIENT WAS ASYMPTOMATIC. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S MOTHER CONFIRMED THE PUMP'S SETTINGS, INCLUDING THE DATE AND TIME WERE CORRECT. THE PATIENT'S MOTHER INFORMED CUSTOMER SUPPORT THAT THE PATIENT WAS RECOVERING FROM AN ILLNESS. CUSTOMER SUPPORT NOTED NO FACTORS CLOUD BE FOUND AT THE TIME OF TROUBLESHOOTING THAT WOULD INDICATE A PUMP MALFUNCTION. THE PATIENT'S MOTHER WAS ADVISED TO CONTACT THE PATIENT'S HCP REGARDING THE PATIENT'S LOW BG. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED A BLOOD GLUCOSE VALUE BELOW 40 MG/DL WHILE ON INSULIN PUMP THERAPY AND INSULIN PUMP USE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R