BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2020556 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00517
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE PUMP'S DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE BLACK BOX AND ALARM HISTORY VERIFIED THE FOLLOWING LOW BATTERY WARNINGS WERE VERIFIED BY THE USER WITHOUT A BATTERY CHANGE OCCURRING: (B)(6) 2010 AT 1:07, (B)(6) 2010 AT 8:43, (B)(6) 2010 AT 20:25, (B)(6) 2010 AT 16:20, (B)(6) 2010 AT 2:35. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED ON THE PUMP. THE PUMP PASSED A FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. NO INSULIN DELIVERY DEFECTS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING ELEVATED BLOOD GLUCOSE LEVELS. THE REPORTER INDICATED THAT PATIENT WAS ADMITTED TO AN EMERGENCY ROOM (ER) ON (B)(6) 2010, FOR DKA AND A BLOOD GLUCOSE (BG) LEVEL OF 504 MG/DL. THE REPORTER ALSO INDICATED THAT THE PATIENT HAD KETONES, DEHYDRATION, NAUSEA, VOMITING, SHORTNESS OF BREATH, CHEST PAIN, AND ABDOMINAL CRAMPS. THE PATIENT WAS REPORTEDLY TREATED WITH AN IV DRIP AND STARTED ON INSULIN INJECTIONS. DURING THE TIME OF CONCERN, THE PATIENT REPORTEDLY HAD BLOOD GLUCOSE READINGS OF "537, 554, 516, 518, 449, 398, 478, 465, 489, 504, 423, 298, AND 409 MG/DL. ON (B)(6) 2010, THE PATIENT REPORTEDLY WOKE UP AT 9:37 AM WITH A BG LEVEL OF "28 MG/DL." DURING TROUBLESHOOTING, THE REPORTER OBSERVED THE SITE AND NOTICED THAT IT WAS BENT AND LAYING ON TOP OF THE SKIN. THE REPORTER DENIED THAT THERE WAS ANY LEAKAGE FROM THE SITE OR AN ODOR OF INSULIN. THE REPORTER ALSO DENIED THAT THE PATIENT HAD AN ILLNESS, OR ANY CHANGES IN MEDICATION OR ACTIVITY. SHE DENIED SEEING BLOOD IN THE TUBING, OR LEAKAGE, REDNESS, WARMTH, OR DRAINAGE AT THE SITE. SHE DID NOT LOOK FOR BUBBLES IN THE TUBING OR CARTRIDGE. THE TDD AND BOLUS HISTORY ADDED UP CORRECTLY. NO OTHER ASSOCIATED ALARMS WERE OBSERVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER ALLEGED THAT THE PATIENT WAS HOSPITALIZED FOR DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| L| R