BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2211841 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05885
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON APPROPRIATELY WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE PATIENT ACTIVATED A "TEMP BASAL CHANGE: -70%" ON (B)(6) 2011. A REVIEW OF THE PUMP HISTORY ALSO REVEALED THAT ON (B)(6) 2011 AT 1:23 PM, THE BASAL RATE WAS SET TO DELIVER 0.4 UNITS/HOUR, ACCURATELY CORRELATING TO WHAT THE PROGRAMMED BASAL RATE SHOULD HAVE BEEN ACCORDING TO THE INITIAL REPORTER. THERE WERE NO INSULIN DELIVERY DEFECTS FOUND ON INVESTIGATION; THE PUMP HISTORIES WERE FOUND TO MATCH THE PROGRAMMED SETTINGS APPROPRIATELY. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED AN INTERMITTENT PCB FAILURE.

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BASAL RATE PROGRAM VIEWED ON THE (B)(4) REPORT AND THE BASAL RATE HISTORY DO NOT SEEM TO MATCH. A FAMILY MEMBER ALLEGED THAT THE PATIENT RECEIVED MORE BASAL INSULIN THAN THE AMOUNT PROGRAMMED. SHE CONTENDED THAT THE BASAL PROGRAM INCONSISTENCIES CORRELATED WITH SEVERAL NON-SPECIFIC LOW BLOOD GLUCOSE READINGS. THE FAMILY MEMBER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANCY. ON (B)(6)2011 THE BASAL HISTORY SHOWED 0.6 UNITS AT 12:00PM WHEN IT SHOULD HAVE BEEN 0.4 UNITS/HOUR. ON (B)(6) 2011, THE BASAL RATE CHANGED FROM 0.4 UNITS/HOUR TO 0.0 UNITS/HOUR WITHOUT ANY USER INTERVENTION. ON (B)(6) 2011, BASAL HISTORY DISPLAYED 0.6 UNITS/HOUR AT 1:23PM WHEN IT SHOULD HAVE READ 0.4 UNITS/HOUR. THE FAMILY DID NOT REPORT ANY BG VALUES, SYMPTOMS OF HYPOGLYCEMIA, OR THE NEED FOR MEDICAL INTERVENTION RELATED TO ALLEGED BG EXCURSIONS. SHE DISCONTINUED THE PATIENT'S USE OF INSULIN PUMP THERAPY AND CALLED THE PATIENT'S HEALTH CARE PROVIDER FOR ASSISTANCE WITH AN ALTERNATE METHOD OF INSULIN DELIVERY. CUSTOMER SUPPORT INSTRUCTED THE FAMILY MEMBER TO CONTACT THE (B)(4) TECHNICAL SUPPORT LINE TO MAKE SURE THE DATA WAS INTERPRETED CORRECTLY.

    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 14 YR