BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3850644 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15879
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/31/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON FOLLOW-UP #1: DATE OF SUBMISSION 07/31/2014 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND MULTIPLE INCIDENCES OF TIME/DATE REVERTING TO DEFAULT SETTINGS FOLLOWING POWER RESETS. TOTAL DAILY DOSE HISTORY SHOWED MULTIPLE INCIDENCES OF DATE RESET AND AS A RESULT THE TOTAL DAILY DELIVERIES APPEARS TO BE INCONSISTENT. BOLUS HISTORY SHOWED THREE BOLUSES OF MAXIMUM AMOUNT BETWEEN 7:00PM AND 9:30PM ON (B)(6) 2007. ON INVESTIGATION, THE PUMP POWERED UP TO A BLANK DISPLAY WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. DUE TO THE BLANK DISPLAY ISSUE THE INVESTIGATION WAS UNABLE TO FULLY INVESTIGATE THE REPORTED DIM DISPLAY ISSUE. A TEST DISPLAY WAS USED TO COMPLETE THE REMAINING TESTING. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR BASAL EXERCISE WERE EXECUTED WITHOUT INCIDENTS. THE PUMP DELIVERY ACCURACY WAS WITHIN SPECIFICATIONS. BOLUS EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. UNRELATED TO THE DISPLAY ISSUE, EVALUATION REVEALED THAT THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD MALFUNCTIONED AND THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. THE INVESTIGATION WAS UNABLE TO VERIFY ANY DELIVERY ISSUES IN THE BLACK BOX DUE TO THE TIME/DATE RESET ISSUE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT RELATED TO A DIM DISPLAY ISSUE. REPORTEDLY, ON (B)(6) 2014, THE PATIENT HAD BLOOD GLUCOSE READING OF 33 MG/DL WITH SLURRED SPEECH, UNSTEADINESS, DIZZINESS OR SEVERE HEADACHE, BLURRED VISION, DISORIENTATION, PROFUSE PERSPIRATION, AND WAS UNCONSCIOUS. EMERGENCY MEDICAL SERVICES WAS CONTACTED AND THE PATIENT WAS GIVEN 50% DEXTROSE FLUIDS INTRAVENOUSLY BY THE EMERGENCY PERSONNEL AND TRANSPORTED TO THE EMERGENCY ROOM. IT WAS REPORTED THAT THE PATIENT REMAINED ON PUMP THERAPY AND NO RECENT ADJUSTMENT TO THE PUMP SETTINGS WAS MADE. IN ADDITION TO DIABETES, THE PATIENT WAS REPORTED TO ALSO HAVE HYPERTHYROIDISM AND HYPERTENSION. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND IT WAS NOTED THAT THE DISPLAY SCREENS WERE DIFFICULT TO READ AND/OR MANEUVER DUE TO THE DIM DISPLAY ISSUE. IT WAS REPORTED THAT THE DISPLAY ISSUE WAS NOT RESOLVED WITH CONTRAST RESET AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA ASSOCIATED WITH AN ALLEGED DIM DISPLAY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330014 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R