BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5678616 · Received May 25, 2016

    Report

    Report Number
    2531779-2016-10464
    Event Type
    Injury
    Date Received
    May 25, 2016
    Report Date
    May 21, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/30/2016 WITH THE FOLLOWING FINDINGS: UNEXPLAINED POR OBSERVED IN THE BB ON (B)(6) 2016 00:48. WHEN PUMP WAS POWERED BACK ON THE TIME/DATE WAS SET TO (B)(6) 2016 00:53. POR OBSERVED AFTER (B)(4) ALARM ON (B)(6) 2016 08:32. WHEN PUMP WAS POWERED BACK ON THE TIME/DATE WAS SET TO (B)(6) 2016 08:25. POR ON (B)(6) 2016 14:12; DELIVERIES RESUMED AT 14:38. POR ON (B)(6) 2016 21:50; DELIVERIES RESUMED AT (B)(6) 2016 00:09. MULTIPLE UNEXPLAINED POR¿S LEADING TO DELIVERY INTERRUPTIONS ALSO OBSERVED IN THE BB BETWEEN 05-17 AND 05-20. THE BATTERY COMPARTMENT IS CRACKED ON THE SIDE FROM THREADS TO COVER. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP. NEW TEST BATTERY CAP IS ABLE TO CAREFULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE A 24HR DURATION TEST; NO POR¿S WERE DUPLICATED DURING THIS TIME. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP COVER WAS REMOVED; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS FOUND. DISPLAY SCREEN HAS A PINKISH CONTRAST. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT'S BLOOD GLUCOSE ON AN UNKNOWN DATE WAS 33 MMOL/L WITH MODERATE KETONES. THE REPORTER NOTED THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, THEY REMAINED ON PUMP THERAPY, AND THE PUMP'S SETTINGS WERE NOT RECENTLY CHANGED. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE PUMP EXPERIENCED AN INTERMITTENT POWER ISSUE. IT WAS REPORTED THE BATTERY COMPARTMENT WAS CRACKED AND THE BATTERY CAP HAD NOT BEEN CHANGED IN MORE THAN 6 MONTHS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HEALTH EVENT WAS ATTRIBUTED TO AN ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334491 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Life Threatening