BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191659 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09065
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. THERE ARE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY OR BLACK BOX; ONLY TYPICAL USAGE OBSERVED. THE DELIVERED BOLUSES AND BASALS ADD UP CORRECTLY TO EQUAL THE TOTAL THE DAILY INSULIN DELIVERY RATE WHICH WAS PROGRAMMED BY THE USER; SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED. PUMP PASSED 29 HOUR FLOW ACCURACY TEST. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN IS DISCOLORED WITH A PINKISH CONTRAST. REMOVED COVER AND REPLACED PINK DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION.

    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. 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. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT¿S MOM/REPORTER CONTACTED ANIMAS ON BEHALF OF THE PATIENT, ALLEGING A POSSIBLE PUMP PROBLEM. THE REPORTER HAS LOST FAITH IN THE SUBJECT PUMP AND FEELS HER SON¿S DIABETES IS BETTER CONTROL WITH INSULIN VIA SYRINGE. THE PATIENT IS HAVING HIGH BLOOD GLUCOSE READINGS. ON ONE OCCASION, THE PATIENT¿S BLOOD GLUCOSE WENT OVER 400 MG/DL AFTER HE HAD A BLOOD GLUCOSE READING OF 130 MG/DL AND ATE A SNACK. THE PATIENT HAD TO TAKE INSULIN VIA SYRINGE TO COMPENSATE AT THE TIME OF CONCERN. THERE WAS NO INDICATION OF A SITE INFECTION. THE DATE AND TIME IS CORRECT. THERE WERE NO ALARMS ASSOCIATED WITH THE REPORTED EVENT. ALL THE ADVANCE SETTINGS ARE CORRECT. PER THE REPORTER, THE TOTAL DAILY DOSE IS NOT CORRECT BASED ON THE FREQUENT INJECTIONS. ON ANOTHER OCCASION, THE PATIENT¿S BLOOD GLUCOSE READING WAS AS LOW AS 66 MG/DL WITH NO SYMPTOMS. THE ANIMAS PUMP WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED INACCURATE DELIVERY ISSUE. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR REQUIRED ANY HCP TREATMENT TO SUGGEST A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291634 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR