BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2083762 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03317
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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 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.

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD ON (B)(6) 2011 FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/17/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES. THERE WERE NO DEFECTS FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT HER BLOOD GLUCOSE WAS LOWERED TO "44 MG/DL" WITH SYMPTOMS OF SHAKY, SWEATY, AND WANTED TO SLEEP AFTER SHE TOOK BOLUS INSULIN FOR TWO BREAKFAST PIZZA AND ONLY CONSUMED ONE PIZZA. HER TARGET BLOOD GLUCOSE IS 120 MG/DL. THE PATIENT STAYED BELOW 120 MG/DL ON THE DAY OF CONCERN UNTIL SHE ATE TWO POP TARTS, AND SODA. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONCLUDED THAT THE INSULIN PUMP IS WORKING ACCORDINGLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT USED THE ANIMAS INSULIN PUMP, REPORTEDLY TOOK TOO MUCH INSULIN FOR THE MEAL SHE ATE AND SUBSEQUENTLY SUFFERED 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 52 YR Life Threatening| R