BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2200113 · Received August 10, 2011

    Report

    Report Number
    2531779-2011-05759
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN BLACK BOX OR DOWNLOAD HISTORY. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HIGH BGS DUE TO CONTINUED USE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    THE PATIENT'S FATHER CONTACTED ANIMAS ON (B)(6) 2011 ALLEGING ELEVATED BLOOD GLUCOSE (BG) READINGS WITH SYMPTOMS OF NAUSEA, VOMITING AND TESTING POSITIVE FOR SMALL KETONES STARTING THE DAY PRIOR. THE PATIENT'S FATHER REPORTED THAT ON (B)(6) 2011 AT 4AM THE PATIENT'S BG WAS 470 MG/DL AND WAS GIVEN A BOLUS OF 7 UNITS BY PUMP. SHORTLY AFTERWARDS HER BG WAS CHECKED AGAIN AND IT WAS 535 MG/DL AND WAS THEN GIVEN 4 UNITS BY INJECTION. AT 5:45AM SHE WAS RETESTED WITH A BG OF 483 MG/DL AND AT 7:06AM HER BLOOD GLUCOSE WAS 407 MG/DL. AT 7:35AM SHE WAS GIVEN AN ADDITIONAL 4 UNITS OF INSULIN BY INJECTION. AT THE TIME OF THE CALL, THE PATIENT'S BG WAS AT 392 MG/DL. THE REPORTER CLAIMED THE PATIENT WAS OBTAINING ELEVATED BG READINGS IN THE 300 MG/DL RANGE THE DAY PRIOR. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S FATHER REPORTED THAT SHE CHANGED SITE ON THE MORNING AND EVENING OF (B)(6) 2011 AND CONFIRMED SITE APPEARED IN GOOD CONDITION ON BOTH OCCASIONS. THE PUMP'S ADVANCED FEATURES WERE REVIEWED AND THE REPORTER CONFIRMED ALL FEATURES WERE PROGRAMMED CORRECTLY INCLUDING THE BOLUS RECOMMENDED BY THE PUMP. REVIEWED ALL BOLUS AND BASAL HISTORY AND CONFIRMED THEY ALL ADDED UP CORRECTLY WITH TOTAL DAILY DELIVERY. THE REPORTER DENIED ANY LEAKS OR AIR BUBBLES IN CARTRIDGE OR TUBING. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, BECAUSE THE PATIENT DEVELOPED SYMPTOMS OF HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY.

    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 10 YR Life Threatening| R