BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2212441 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05892
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    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: A REVIEW OF THE TOTAL DAILY DOSE SHOWED THAT THE INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THE BLACK BOX SHOWED TYPICAL USAGE ALARMS AND WARNINGS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING INSULIN WITHIN SPECIFICATIONS.

    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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT CLAIMED THAT THERE WAS AN ISSUE WITH THE PUMP AND DEMANDED THAT IT BE REPLACED. THROUGH TROUBLESHOOTING, AN ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT DETERMINED THAT THERE WAS NO EVIDENCE OF A MECHANICAL ISSUE WITH THE PUMP. THE ANIMAS REPRESENTATIVE ATTRIBUTED THE PATIENT'S ELEVATED BG LEVELS TO A POSSIBLE SITE ISSUE. THE PATIENT HAD BEEN USING A PUMP FOR 6 YEARS AND WAS ONLY USING HER ABDOMEN. SHE DENIED THAT THE SITE(S) WERE LEAKING, RED, HARD, OR HAD SCAR TISSUE. THE PATIENT DENIED THAT THE CARTRIDGE(S) OR INFUSION SET HAD AIR BUBBLES, OR THAT THE CANNULA WAS BENT. A REVIEW OF THE PUMP HISTORY REVEALED THAT THERE WERE NO FILL CANNULAS. THE PATIENT WAS UNSURE AS TO WHY THERE WERE NO FILL CANNULAS IN THE PUMP HISTORY. THERE WERE NO RECENT ALARMS IN THE PUMP'S ALARM HISTORY. WHILE USING THE PUMP, THE PATIENT CLAIMED THAT HER BG LEVELS REACHED "HIGH" AND "510 MG/DL" ON A METER. THE PATIENT ALSO CLAIMED THAT HER BG LEVELS CAME DOWN TO NORMAL LEVELS WHEN SHE SELF-TREATED WITH INJECTIONS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THERE WAS AN ISSUE WITH THE PUMP AND SHE DEVELOPED ELEVATED BG LEVELS SUGGESTIVE OF A SERIOUS INJURY.

    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 46 YR Life Threatening| R