BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2420278 · Received January 18, 2012

    Report

    Report Number
    2531779-2012-00432
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY.

    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. CORRECTION/REMOVAL REPORTING NUMBER: 2531779-03/24/2010/003-R.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT DURING THE LOAD STEP, THE PUMP WAS PUSHING INSULIN FORWARD. THE PATIENT CLAIMED THAT EARLIER THAT DAY AT AN UNSPECIFIED TIME, HIS BLOOD GLUCOSE (BG) LEVEL WAS AT "90 MG/DL." AFTER SLEEPING, THE PATIENT CLAIMED THAT HIS BG LEVEL ROSE TO "500 MG/DL" WITH NO SIGNS OR SYMPTOMS. THE PATIENT DID NOT CHECK FOR KETONES OR REPORT THAT HE RECEIVED TREATMENT BECAUSE OF THE ALLEGED ISSUE. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP PUSHED INSULIN FORWARD DURING THE LOAD STEP AND HE DEVELOPED AN ELEVATED BG LEVEL THAT CAN BE ASSOCIATED WITH SEVERE HYPERGLYCEMIA.

    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 42 YR Life Threatening