BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5706535 · Received June 8, 2016

    Report

    Report Number
    2531779-2016-11309
    Event Type
    Injury
    Date Received
    June 8, 2016
    Date of Event
    May 15, 2016
    Report Date
    May 16, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/03/2016 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY REVEALED A LOW BATTERY WARNING ON (B)(6) 2016 AT 14:32 FOLLOWED BY A REPLACE BATTERY ON (B)(6) 2016 05:47. THE NEXT PRIME WAS RECORDED ON (B)(6) 2016 AT 08:20. A REPLACE CARTRIDGE ALARM WAS RECORDED ON (B)(6) 2016 21:28; THE NEXT PRIME WAS RECORDED ON (B)(6) 2016 21:31. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP. A NEW TEST BATTERY SECURED TO THE PUMP WITH NO ISSUES. THE PUMP BOOTED TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY TONE. THE PUMP COMPLETED THE 24 HOUR DURATION TEST WITH NO POWER ON RESET EVENTS. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED THE DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. THE PUMP COVER WAS REMOVED; THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE FOUND TO THE POWER CIRCUIT. 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 05/16/2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT WAS HOSPITALIZED ON (B)(6) 2016 WITH HYPERGLYCEMIA. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE LEVEL OVER 600 MG/DL WITH SYMPTOMS OF STRONG FRUITY BREATH, RAPID BREATHING, EXTREME DROWSINESS, BLURRED VISION, EXTREME THIRST, EXTREME URINATION, SYMPTOMS OF DEHYDRATION, CHEST PAINS, AND LARGE KETONES. THE REPORTER STATED THAT THE PATIENT HAD DISCONTINUED PUMP THERAPY FOLLOWING THE ALLEGED EVENT. WHILE HOSPITALIZED, THE PATIENT ALLEGEDLY RECEIVED INTRAVENOUS FLUIDS AND INSULIN VIA INJECTION. THE REPORTER ALLEGED THAT THE HYPERGLYCEMIC EVENT WAS A RESULT OF THE PUMP NOT HAVING POWER. THE REPORTER REVIEWED THE PUMP WITH A CUSTOMER TECHNICAL SUPPORT (CTS) REPRESENTATIVE AND FOUND THAT THERE WERE REPLACE BATTERY ALARMS THAT LEAD TO THE POWER LOSS. IT WAS INDICATED THAT THE PATIENT DID NOT CHANGE THE BATTERY INITIALLY IN RESPONSE TO THE BATTERY RELATED ALARMS. THE REPORTER WAS INSTRUCTED TO PLACE A NEW BATTERY IN THE PUMP AND THE PUMP POWERED ON PROPERLY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA AS A RESULT OF THE PUMP LOSING POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361311 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| L| R