BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2141738 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04508
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL INFORMATION: PATIENT OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS OMITTED IN ERROR ON THE 3500A.

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4): THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY. THE PUMP HISTORY FROM THE DATE OF THE EVENT WAS NOT AVAILABLE DUE TO BEING OVERWRITTEN. THE PUMP WAS ABLE TO REWIND, LOAD AND PRIME SUCCESSFULLY AND WAS EXERCISED FOR 24 HOURS WITH NO ISSUES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF HER SON (THE PATIENT) AND REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR DKA ON (B)(6) 2011. THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL BEGAN TO ELEVATE THE MORNING OF (B)(6) 2011 AND DID NOT COME DOWN. UPON ADMISSION TO THE HOSPITAL, THE PATIENT'S BG LEVEL WAS REPORTEDLY "550 MG/DL." THE PATIENT WAS DISCONNECTED FROM THE PUMP AND TREATED WITH AN IV INSULIN DRIP. AFTER RECEIVING TREATMENT, THE PATIENT'S BG LEVEL CAME DOWN TO THE "200 MG/DL" RANGE. AT AN UNSPECIFIED TIME DURING THE TIME OF CONCERN, THE REPORTER INDICATED THAT THE PATIENT'S BG LEVEL WENT UP INTO THE "300 MG/DL" RANGE AFTER GOING BACK ON THE PUMP. THE REPORTER DID NOT HAVE THE PUMP FOR TROUBLESHOOTING DURING THE CALL. HOWEVER, A FOLLOW-UP CALL WAS MADE DIRECTLY WITH THE PATIENT ON (B)(6) 2011, AT AN UNSPECIFIED TIME. THE PUMP BASAL TDD BASAL HISTORY MATCHED THE BASAL SETTINGS. THE PUMP WAS ALSO CONFIRMED TO HAVE A CORRECT TIME. THE BOLUS HISTORY WAS ALSO REPORTEDLY CORRECT. THE PATIENT ALSO PROGRAMMED A NORMAL AIR BOLUS AND CONFIRMED SEEING INSULIN COMING OUT OF THE END OF THE TUBING. NO ASSOCIATED ALARMS WERE NOTED IN THE PUMP HISTORY. UPON REMOVING THE CURRENT SITE, THE PATIENT OBSERVED A LOT OF BLOOD IN HIS CANNULA/SITE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER INDICATED THAT THE PATIENT WAS HOSPITALIZED FOR DKA. HOWEVER, THE REPORTED INJURY CAN BE ATTRIBUTED TO POSSIBLE USER-ERROR SINCE BLOOD WAS OBSERVED IN THE CANNULA/SITE.

    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 27 YR Hospitalization| L| R