BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5818572 · Received July 25, 2016

    Report

    Report Number
    2531779-2016-17283
    Event Type
    Injury
    Date Received
    July 25, 2016
    Report Date
    July 3, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/19/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/25/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX REVEALED A 128-FB80 REPLACE BATTERY ALARM ON (B)(4) 2016 AT 03:38; DELIVERIES RESUMED AT 03:57. 128-FB80 REPLACE BATTERY ALARMS WAS OBSERVED ON (B)(4) 2016 AT 04:18; FOLLOWED BY TWO 128-FE80 REPLACE BATTERY ALARMS AT 04:31 AND 04:44; DELIVERIES NEVER RESUMED. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. NO 128-FXXX ALARMS WERE DUPLICATED DURING INVESTIGATION. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED THE DELIVERY ACCURACY TEST WITH NO DELIVERY DEFECTS FOUND. THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THE REPORTED COMPLAINT WAS VERIFIED IN HISTORY BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED BELOW THE BUMPER PAD. THE PUMP COVER WAS REMOVED; THERE WAS EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE THE PUMP ON THE AUDIO BOLUS BUTTON CONNECTOR, IN THE AREA OF THE MOTOR CIRCUIT AND SURROUNDING AREA. 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 (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER SHORT BATTERY LIFE 128 ISSUE. THE PATIENT REPORTEDLY WAS ADVISED TO DISCONNECT FROM THE PUMP AND TO GO TO EMERGENCY ROOM TO ACQUIRE AN ALTERNATE FORM OF INSULIN AS THE ISSUE WAS UNABLE TO BE RESOLVED. THERE WAS NO REPORTED BLOOD GLUCOSE MEASUREMENTS OR SYMPTOMS AT THE TIME THE INCIDENT WAS REPORTED. ANIMAS CUSTOMER TECHNICAL SUPPORT REPORTEDLY REVIEWED THE PUMP WITH THE PATIENT. A REVIEW OF THE PUMP HISTORY INDICATED MULTIPLE 128 ALARMS WITHIN THE PAST 30 DAYS. THERE WAS NO INDICATION OF UNACKNOWLEDGED ALARMS OR WARNINGS. THE PATIENT REPORTEDLY USED THE CORRECT BATTERY TYPE PER INSTRUCTIONS FOR USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED AN ADVERSE EVENT ALLEGEDLY DUE TO THE USER NOT BEING ABLE TO RESOLVED THE ALARM RESULTING IN LONG TERM CESSATION OF INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472002 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR