BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2103522 · Received May 26, 2011

    Report

    Report Number
    2531779-2011-03724
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 2, 2011
    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

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON APPROPRIATELY DURING INVESTIGATION, WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. A REVIEW OF THE PUMP HISTORY FROM (B)(6) 2011 TO (B)(6) 2011 DID NOT INDICATE THAT REBOOTING OCCURRED. THE POWER LOSS COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP REBOOTED WITHOUT USER INTERVENTION. SHE SAID HER BLOOD GLUCOSE LEVELS WERE 300-400 MG/DL ON THE MORNING THAT THE PUMP REBOOTED. SHE DENIED KETONES AND SYMPTOMS. THE SITUATION IS NOT INDICATIVE OF A SERIOUS INJURY. SHE SAID HER BLOOD GLUCOSE ELEVATIONS WERE RESOLVED WHEN THE PUMP REGAINED POWER. THE DATE AND TIME WERE CORRECT ON THE PUMP AND THE BATTERY CAP WAS ABLE TO SECURELY TIGHTEN TO RESISTANCE. THE PATIENT HAS NEVER CHANGED THE BATTERY CAP AND A NEW BATTERY . THERE WAS NO EVIDENCE OF MISUSE OF THE PRODUCT AND THE REBOOTING ISSUE COULD NOT BE RESOLVED.

    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 6 YR