BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2182674 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05390
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2011. THE PUMP BOOTED TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY ALARMS. THE DISPLAY WAS OBSERVED TO HAVE A REDDISH TINT THAT MADE THE INFORMATION DIFFICULT TO READ. A TEST DISPLAY WAS INSERTED TO COMPLETE REMAINDER OF INVESTIGATION. THE DATE AND TIME WERE SET CORRECTLY BUT REVERTED TO DEFAULT TIME AND DATE UPON REBOOT AFTER THE PUMP WAS RESTED FOR ONE HOUR WITHOUT POWER. NO OCCLUSIONS OCCURRED DURING AN EZPRIME OPERATION BUT OCCLUSIONS WERE OBSERVED IN THE PUMP HISTORY; NO OCCLUSIONS OCCURRED DURING THE 24 HOUR EXERCISE. A LEAK IN THE BACKUP BATTERY AT THE BT1 LOCATION WAS OBSERVED AFTER DISASSEMBLY OF THE PUMP. UNRELATED TO THE COMPLAINT, THE PUMP FAILED FORCE SENSOR CALIBRATION; A DIMPLED FORCE SENSOR SPOKE SHIM WAS OBSERVED ALONG WITH CONTAMINATION AROUND THE SHIM. THE FORCE SENSOR FAILED RESISTANCE SPECIFICATIONS. RECALL #2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE HAS BEEN ELEVATED FOR (B)(6) SINCE SHE CHANGED THE BATTERY ON THE ANIMAS PUMP. THE PATIENT HAD SYMPTOMS DESCRIBED AS "NAUSEA, VOMITING, AND LARGE KETONES." DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE DISCOVERED THAT THE PATIENT'S DATE AND TIME WAS SET INCORRECTLY TO 27 HOURS AHEAD. THE PATIENT COULD NOT GO THROUGH WITH THE COMPLETE TROUBLESHOOTING AT THE TIME OF CONCERN AND WAS ASKED TO CALL BACK. IT IS NOT KNOWN WHAT ATTRIBUTED TO THE PATIENT ELEVATED BLOOD GLUCOSE AND REPORTED SYMPTOMS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF A SERIOUS INJURY WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening