BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2212472 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05908
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. 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

    DEVICE EVALUATION (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. 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 LOW BGS DUE TO CONTINUED USE.

    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 FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED BLOOD GLUCOSE (BG) LEVELS AS LOW AS 23 MG/DL WITH TIREDNESS AND SHAKINESS DURING THE NIGHT AND AT RANDOM DURING THE DAY. THE PATIENT REPORTED THAT SHE TREATED LOW BGS WITH ORAL CARBOHYDRATES. THE PATIENT ORIGINALLY CONTACTED CUSTOMER SUPPORT (CS) FOR ASSISTANCE ENTERING NEW SETTINGS FROM HER DOCTOR; THE CURRENT INSULIN TO CARBOHYDRATE (I:C) SETTING ACCORDING TO THE DOCTOR DID NOT MATCH THE PATIENT'S CURRENT I:C RATIO IN THE PUMP. THE PATIENT HAD I:C RATIOS IN PUMP: 12AM 1UNIT:30GRAMS, 6AM 1UNIT:25GRAMS; HOWEVER, THE DOCTOR HAD 4 TIME SEGMENTS, ALL OF WHICH HAD AN I:C RATIO OF 1UNIT:30 GRAMS. THE DOCTOR PRESCRIBED NEW I:C RATIOS OF 12AM 1UNIT:30GRAMS, 6AM 1UNIT:20GRAMS, 9AM 1UNIT:30GRAMS, 11AM 1UNIT:25GRAMS. THE PATIENT'S TARGET BG ALSO VARIED FROM THE DOCTOR'S RECORDS. THE DOCTOR'S RECORDS SHOWED A TARGET OF 120MG/DL BUT THAT PATIENT'S SETTING IN THE PUMP WAS 145MG/DL +/- 30 MG/DL. THE PATIENT REPORTEDLY STARTED TAKING SIMVASTATIN IN (B)(6) 2011. THE PATIENT REPORTED THAT SHE ALSO LOST SOME WEIGHT DUE TO MULTIPLE STRESS FACTORS; THE PATIENT USED TO BE (B)(6) AND NOW IS (B)(6). THE PATIENT REPORTED THAT SHE RECENTLY HAD AN ACCIDENT AT WORK AND WAS GOING FOR PHYSICAL THERAPY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE USING 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 52 YR Required Intervention