BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4914759 · Received July 15, 2015

    Report

    Report Number
    2531779-2015-23759
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Report Date
    June 29, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/25/2015-DEVICE EVALUATION: THE PUMP AND CARTRIDGE WERE RETURNED AND EVALUATED BY PRODUCT ANALYSIS. THE RETURNED CARTRIDGE WAS EVALUATED ON 08/11/2015. THE UPPER O-RING OF THE CARTRIDGE PLUNGER WAS FOUND TO BE PINCHED BETWEEN THE PLUNGER AND THE CARTRIDGE BARREL. THE RETURNED PUMP WAS EVALUATED ON 08/24/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED MULTIPLE LOSS OF PRIMES DUE TO LOW NON-ZERO FORCE HAD OCCURRED. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. DURING TESTING, THE PUMP POWERED ON AND IMMEDIATELY EMITTED A CS 127 BATTERY ALARM. THE PUMP CASE WAS REMOVED AND THE VOLTAGE OF A COMPONENT ON THE PCB WAS FOUND TO BE OUT OF SPECIFICATION. THE COMPONENT WAS REPLACED AND THE PUMP WAS ABLE TO POWER ON TO THE VERIFY SCREEN WITH NORMAL VOLTAGE. THERE WERE NO INTERMITTENT CONDITIONS OBSERVED TO THE FORCE SENSOR FLEX OR PINS. THE COMPLAINT OF A LOSS OF PRIME ISSUE WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE DEFECTIVE COMPONENT.

    Additional Manufacturer Narrative · 1

    THE PUMP 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP REPEATEDLY EMITTED LOSS OF PRIME WARNINGS DESPITE CARTRIDGE CHANGES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459195 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR