BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2071756 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02951
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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: THE DATA FROM THE TIME OF THE REPORTED INCIDENT IS UNAVAILABLE FOR REVIEW. A REVIEW OF THE CURRENT 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. 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.

    Additional Manufacturer Narrative · 1

    SINCE THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION, THE PRODUCT WAS NOT REQUESTED BACK. 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 CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE ELEVATED TO 530 MG/DL WITH SYMPTOMS OF NAUSEA. REPORTEDLY, THE PATIENT WENT TO BED WITH A BLOOD GLUCOSE READING OF 180 MG/DL AND WOKE UP WITH THE REPORTED HIGH READING. SUBSEQUENTLY, THE PATIENT TOOK AN INSULIN INJECTION AND HIS/HER BLOOD GLUCOSE LOWERED TO 236 MG/DL. DURING TROUBLESHOOTING, THE REPORTER INDICATED THERE WAS AN OCCLUSION ISSUE AFTER THE SITE WAS CHANGED. THE ANIMAS HEALTHCARE REPRESENTATION MADE SURE THE PATIENT'S TECHNIQUE WAS CORRECT. SINCE THE ANIMAS REPRESENTATIVE CONCLUDED THE INSULIN PUMP WORKED ACCORDINGLY, THE PATIENT WAS CONSULT WITH HER DOCTOR TO HAVE THE OVERNIGHT BASAL RATES ADJUSTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WHILE MANAGING HER DIABETES WITH THE ANIMAS PRODUCT.

    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 7 YR Life Threatening| R