BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2658577 · Received July 17, 2012

    Report

    Report Number
    2531779-2012-06560
    Event Type
    Injury
    Date Received
    July 17, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 09/06/2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/08/2012 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED AN UNCONFIRMED AUTO OFF ALARM ON (B)(6) 2012. THE PUMP WAS EXERCISED FOR 24 HOURS ON A ONE UNIT PER HOUR BASAL RATE WITH RETURNED BATTERY CAP AND NO POWER LOSS OR REBOOTING WAS DUPLICATED. THERE WAS NO DAMAGE OBSERVED TO THE CATTERY COMPARTMENT OR RETURNED BATTERY CAP. THE PUMP PASSED A BATTERY CAP FUNCTIONAL TEST AND THE BATTERY CAP CONTACT HEIGHT WAS MEASURED AND WAS IN SPECIFICATIONS. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED DISPLAY SCREEN AND THE KEYPAD SYMBOLS WERE WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) AND REPORTED A HIGH BLOOD GLUCOSE (BG) EPISODE. THE PATIENT ALSO ALLEGED THAT THE PUMP WAS NOT WORKING AND WAS REBOOTING. THE PATIENT CLAIMED THAT THE PUMP REBOOTED SEVERAL TIMES AND WAS GOING TO THE VERIFY SCREEN. AT THE TIME OF CONTACT WITH ANM, THE PATIENT'S BG LEVEL WAS "320 MG/DL." SHE HAD SYMPTOMS OF SHORTNESS OF BREATH AND NAUSEA. SHE DENIED HAVING SYMPTOMS OF VOMITING OR CHEST PAIN. UPON INSPECTION OF THE PUMP, THE PATIENT NOTICED THAT THE BATTERY COMPARTMENT THREADS WERE DAMAGED AND FLAT. IT IS UNCLEAR WHEN THE THREADING DAMAGED WAS FIRST NOTICED BY THE PATIENT IN RELATION TO WHEN THE POWER ISSUE BEGAN. SHE DENIED THAT THE PUMP HAD ANY CRACKS. THE PATIENT ADMITTED THAT THE BATTERY CAP WAS LAST REPLACED A YEAR AGO. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PUMP WAS REPLACED. THE PATIENT WAS ON A BACKUP PLAN FOR INSULIN DELIVERY DURING THE CONTACT WITH ANM. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP WAS REBOOTING AND SHE DEVELOPED AN ELEVATED BG LEVEL WITH SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPERGLYCEMIA. HOWEVER, IT IS UNKNOWN AT THIS TIME IF THE PUMP ISSUE AND/OR USE-ERROR ACTUALLY CONTRIBUTED TO THE PATIENT'S INJURY.

    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 18 YR Life Threatening