BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6046272 · Received October 21, 2016

    Report

    Report Number
    2531779-2016-29330
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT RECORD INDICATED THAT THE ALLEGED ISSUE WAS DEEMED TO BE ONE OF POWER/INTERMITTENT POWER, RELATED TO THE CRACKED BATTERY COMPARTMENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED 12/12/2016 THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 11/14/2016 WITH THE FOLLOWING RESULTS. THE BLACK BOX SHOWS AN UNEXPLAINED LOSS OF PRIME ON (B)(6) 2016 07:53, FOLLOWED BY MANUAL SUSPENDS AND ONE UNEXPLAINED POR ON (B)(6) 2016 14:47.; DELIVERIES NEVER RESUMED. THE BLACK BOX SHOWS AN UNEXPLAINED LOSS OF PRIME ON (B)(6) 2016 07:53, FOLLOWED BY MANUAL SUSPENDS AND ONE UNEXPLAINED POR ON (B)(6) 2016 14:47.; DELIVERIES NEVER RESUMED. BATTERY COMPARTMENT IS CRACKED "DON¿T THE SIDE AT THE THREADS". RETURNED BATTERY CAP HAS STRIPPED THREADS AND WORN TOP; IT IS UNABLE TO FULLY ATTACH TO THE PUMP; POWER ON RESETS WERE DUPLICATED WITH RETURNED BATTERY CAP. NEW TEST BATTERY CAP IS ABLE TO CAREFULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE A 24 HR DURATION TEST; NO POWER INTERRUPTIONS WERE DUPLICATED DURING THIS TIME. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. THE PUMP COVER WAS REMOVED; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND REPORTED THE PATIENT BEING HOSPITALIZED WITH A BLOOD GLUCOSE (BG) OF 706 MG/DL WITH MODERATE KETONES. SYMPTOMS INCLUDED EXTREME THIRST, AND DIFFICULTY BREATHING. TREATMENT INCLUDED IV GLUCOSE. DURING TROUBLESHOOTING, THE PATIENT THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS COMPLAINT IS BEING REPORTED AS THIS ISSUE MAY RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT , AND THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699155 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization