BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2073353 · Received May 1, 2011

    Report

    Report Number
    2531779-2011-03004
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1, (B)(6) 2011 - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE HISTORY WAS REVIEWED TO THE END OF PUMP USE ON (B)(6) 2011 AND DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN THE DOWNLOAD HISTORY OR ALARM HISTORY. THE PUMP ACCURATELY DELIVERS 2.00 UNITS/HR FOR (B)(6). THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER ALLEGED THAT THE ANIMAS INSULIN PUMP IS NOT GIVING THE CORRECT AMOUNT OF INSULIN BECAUSE THE PATIENT'S BLOOD GLUCOSE HAS BEEN ELEVATED TO "350 MG/DL" OR HIGHER WITH SYMPTOMS OF KETONES, NAUSEA, AND VOMITING. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE READING DID NOT LOWER FOR 24 HOURS. THE PATIENT USED TO THE ANIMAS PUMP TO PROVIDE HER BASAL RATE AND BOLUSED WITH THE INSULIN PEN. HER BLOOD GLUCOSE EVENTUALLY LOWERED TO 250 MG/DL. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONCLUDED THAT THE ANIMAS INSULIN PUMP IS WORKING ACCORDINGLY. THERE WAS NO PRODUCT MISUSED OR SIGNS OF TRAUMA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ONSET OF THE ALLEGED INSULIN DELIVERY ISSUE.

    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 56 YR Life Threatening| R