BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2133965 · Received June 20, 2011

    Report

    Report Number
    2531779-2011-04280
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: 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

    FOLLOW-UP #1 08/26/2014. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX AND HISTORY FROM THE TIME OF THE EVENT WAS OVERWRITTEN DUE TO CONTINUED PATIENT USE. THE PUMP DAILY DELIVERY TOTALS APPEARED INCONSISTENT IN THE PUMP DUE TO AN UNRELATED ISSUE. A 29 HOUR FLOW ACCURACY TEST WAS COMPLETED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE (BG) OF 45 MG/DL, AND WAS TAKEN TO THE ER. THE PATIENT STATED THAT SHE WAS TREATED AND RELEASED, AND HER BG AT THE TIME OF THE CALL TO CUSTOMER SUPPORT (CS) WAS 92 MG/DL. SHE NOTED THAT SHE WAS NOT ON THE PUMP AT THE TIME OF THE CALL TO CS. CS REVIEWED THE PUMP WITH THE PATIENT AND FOUND THAT TIME AND DATE SETTINGS WERE CORRECT. A REVIEW OF THE PUMP HISTORY INDICATED THAT AN "AUTO OFF" ALARM OCCURRED, AND THE PATIENT PRIMED THE PUMP TO CLEAR THE ALARM. THE PATIENT STATED THAT SHE DID NOT DISCONNECT FROM THE INFUSION SET PRIOR TO PRIMING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA WHILE USING THE PUMP AND THE POSSIBILITY OF USE ERROR CANNOT BE RULED OUT.

    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 61 YR