BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2120884 · Received June 11, 2011

    Report

    Report Number
    2531779-2011-04074
    Event Type
    Injury
    Date Received
    June 11, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    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

    FOLLOW-UP #1 07/21/2011. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(6) 2011 AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HIGH BGS DUE TO CONTINUED USE. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. NO DEFECT WAS FOUND. TWENTY-NINE HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE HAS BEEN RANGING FROM 122 MG/DL TO HI (ABOVE 600 MG/DL) FOR (B)(6) WHILE THE PATIENT MANAGES HIS DIABETES WITH THE ANIMAS PUMP. THE PATIENT'S NORMAL BLOOD GLUCOSE TARGET IS FROM 100 MG/DL TO 200 MG/DL. DURING TROUBLESHOOTING, THE REPORTER NOTED THE FOLLOWING: THE INSULIN SITE HAS BEEN CHANGED 3 TIMES THE NIGHT BEFORE. THERE WERE NO CHANGES IN MEDICATION OR PHYSICAL ACTIVITY. THE REPORTER PRIMED 23 UNITS OF INSULIN WITHOUT SEEING A DROP OF INSULIN ON OTHER END. ELEVEN MORE UNITS OF INSULIN WERE PRIMED BEFORE THE REPORTER SAW INSULIN AT THE END OF THE TUBING. THE ANIMAS PUMP MOTOR SOUNDED SLOW. ON (B)(6) 2011 AT 8 PM, THE PATIENT BLOOD GLUCOSE LOWERED TO 123 MG/DL WITH INJECTION VIA SYRINGE. HOWEVER, THE PATIENT'S BLOOD GLUCOSE WENT BACK TO 400+ MG/DL AFTER THE PATIENT RESUME THE ANIMAS PUMP TREATMENT. THE REPORTER FEELS THAT THE ANIMAS PUMP IS NOT DELIVERING SUFFICIENT AMOUNTS OF INSULIN AS THE PATIENT'S BLOOD GLUCOSE IS ELEVATED WHEN HE RESUMES HIS PUMP TREATMENT. THE REPORTER DID NOT HAVE THE INSULIN WITH HER AT THE TIME OF TROUBLESHOOTING. HENCE, THE REPORTED ISSUE COULD NOT BE RESOLVED AT THE TIME OF CONCERN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S BLOOD GLUCOSE ALLEGEDLY WAS ELEVATED ABOVE 500 MG/DL WHILE THE PATIENT MANAGED HIS DIABETES WITH ANIMAS PUMP.

    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 9 YR Life Threatening| R