BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2192307 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05628
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE OBSERVED IN THE PUMP'S HISTORY. THERE WAS NO DATA FOUND IN THE PUMP'S HISTORY FROM THE TIME OF THE REPORTED OCCLUSIONS DUE TO CONTINUED PATIENT USE. THE REWIND, LOAD, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS NOTED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A FORCE SENSOR CALIBRATION TEST WAS FOUND TO DETECT THE CORRECT FORCE. THERE WERE NO OCCLUSIONS FOUND DURING TESTING. AN OCCLUSION WAS INDUCED DURING A 10 UNIT BOLUS BY BLOCKING THE TUBING; THE APPROPRIATE ALARMS WERE EMITTED BY THE PUMP AND WERE SUCCESSFULLY RECORDED IN THE PUMP'S HISTORY.

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE PATIENT, THE ANIMAS PUMP GAVE HER ONE OCCLUSION ALARM ON THE NIGHT OF (B)(6) 2011. THE PATIENT CLAIMED THAT SHE OBTAINED ELEVATED BLOOD GLUCOSE READING OF "311 MG/DL" AND SYMPTOMS OF FREQUENTLY URINATION ON THE MORNING OF (B)(6) 2011. THE ANIMAS REPRESENTATIVE TROUBLESHOOT THE PATIENT'S ELEVATED BLOOD GLUCOSE WITH FURTHER INVESTIGATION. THE PATIENT WAS ABLE TO PRIME THE SUBJECT PUMP WITHOUT ANY MECHANICAL ISSUE OR OCCLUSION ISSUE. SINCE THE INFUSION SITE AND SET WAS NOT CHANGED SINCE THE ALARM OCCURRED, THE ANIMAS REPRESENTATIVE ADVISED THE PATIENT TO CHANGE THE INFUSION SITE. THERE WAS NO PRODUCT MISUSE. THERE WAS NO RECURRENCE OF THE OCCLUSION ISSUE. THE REPORTED ISSUE WAS RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED DUE TO A POSSIBLE USER ERROR ISSUE AND BECAUSE THE PATIENT HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA. THE ALLEGED PRODUCT ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE (B)(4) INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON.

    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 26 YR Life Threatening