BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3173648 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08363
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION; HOWEVER, PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED. ONCE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/24/2013 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. NO DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE TOTAL DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT HIS BLOOD GLUCOSE READINGS ARE ELEVATED TO 552 MG/DL WITH SYMPTOMS OF MODERATE THIRST AND FREQUENT URINATION WHEN HE MANAGES HIS DIABETES WITH THE ANIMAS PUMP. FURTHERMORE, THE PATIENT¿S DOCTOR HAS DONE A TEST RUN USING INSULIN VIA INJECTIONS. REPORTEDLY, THE PATIENT¿S BLOOD GLUCOSE WAS NORMAL THE ENTIRE TIME HE WAS ON INJECTION. THE PATIENT¿S DOCTOR FELT THAT THE ANIMAS PUMP IS NOT WORKING CORRECTLY AND INSISTED THAT THE SUBJECT ANIMAS PUMP BE REPLACED. THE PATIENT IS CURRENTLY OFF OF INSULIN PUMP THERAPY AND IS ON INSULIN VIA SYRINGES. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENTS ALLEGED BLOOD GLUCOSE EXCURSION BY EVALUATING THE ANIMAS PUMP. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT¿S USAGE. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE SUBJECT PUMP DELIVERED INSULIN ACCORDINGLY WITHOUT ANY ISSUE. THE PATIENT DENIED ANY ISSUE WITH THE SITE. HE REPORTEDLY USES THE SAME AREA FOR SYRINGE INJECTION AS HE DID FOR THE INFUSION SET SITE. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD ELEVATED READING ABOVE 500 MG/DL WHILE ON INSULIN PUMP THERAPY. THE ANIMAS PUMP WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273654 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R