BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2110924 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03866
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011, SHE EXPERIENCED BLOOD GLUCOSE (BG) OF 594 MG/DL. THE PATIENT REPORTED HAVING AN EMPTY CARTRIDGE ALARM AND SHE WAS WITHOUT INSULIN FOR 40 MINUTES. SHE ALSO REPORTED THAT SHE WAS STRESSED DUE TO AN UPCOMING DENTAL PROCEDURE. THE PATIENT REPORTEDLY CHANGED THE CARTRIDGE AND SITE AND WAS ABLE TO CORRECT VIA SYRINGE AND PUMP. THE PATIENT'S BG HAS RETURNED TO TARGET RANGE ON (B)(6) 2011. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE PATIENT. THE PATIENT CONFIRMED THAT THE BOLUS, SUSPEND, AND PRIME HISTORIES WERE CORRECT. SHE CONFIRMED THAT SHE DID NOT HAVE ANY SITE ISSUES HOWEVER, SHE REPORTED THAT THERE WERE BUBBLES IN THE TUBING. CUSTOMER SUPPORT CONCLUDED THAT THERE WERE NO MECHANICAL PROBLEMS FOUND WITH THE PUMP. THIS REPORT IS MADE BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 57 YR