BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3122766 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06832
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/01/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED THE TIME AND DATE RESETTING TO DEFAULT FOLLOWING A REBOOT AT 12:48PM ON (B)(6) 2014; THE TIME WAS THEN MANUALLY SET TO 1:00AM ON (B)(6) 2014. THE DAILY INSULIN DELIVERY TOTALS APPEARED INCONSISTENT DUE TO THE TIME/DATE ISSUE. THERE WAS NO DATA IN THE PUMP HISTORIES FROM THE TIME OF THE ALLEGED BG EXCURSION DUE TO CONTINUED PUMP USE. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY, AND THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE KEEPING TIME APPROPRIATELY. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CLAIMED HE HAD BLOOD GLUCOSE READING AS LOW AS 41 MG/DL FOR THE LAST SEVERAL WEEKS WHILE HE HAD THE AM AND PM SETTING INCORRECTLY SET. AT THE TIME OF CONCERN, THE PATIENT WAS CONFUSED AND WAS ABLE TO ADMINISTER SELF TREATMENT WITH FOOD ((B)(6)). THE TIME SETTING ISSUE BEGAN AFTER THE PATIENT HAD RECENTLY RECEIVED HIS REPLACEMENT PUMP. DURING TROUBLESHOOTING, THE AM/PM ISSUE WAS RESOLVED WITH TRAINING. THE BASAL SETTING REPORTEDLY WAS SET CORRECTLY. THE DATE/TIME WAS MAINTAINED WHEN THE BATTERY WAS REMOVED FOR LESS THAN 24 HOURS. THIS COMPLAINT IS BEING REPORTED DUE TO USE ERROR (INCORRECT AM/PM SETTING) AND BECAUSE THE PATIENT HAD READINGS OF AS LOW AS 41 MG/DL WHILE ON INSULIN PUMP THERAPY. BASED ON THE INFORMATION PROVIDED, THE BASAL DOSAGE COULD BE INCORRECTLY REVERSE IF THE AM AND PM IS NOT SET CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224174 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening