BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSP SS FLEXX METER W/O LASER

    MDR report key: 2091776 · Received May 17, 2011

    Report

    Report Number
    2939301-2011-04104
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 510(K) # IS K081019.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE POINT OF CARE CONTACT (POCC) FOR THE HOSPITAL (B)(6) CONTACTED LIFESCAN (LFS) TO REPORT A COMMUNICATION ISSUE BETWEEN ONE OF THEIR (B)(6) HOSPITAL METERS AND A SPECIFIC COMPUTER. THE POCC CLAIMED THAT THEIR (B)(6) HOSPITAL METERS WERE UNABLE TO DOWNLOAD DATA FROM ONE SPECIFIC UNIT (6A). THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL. THE POCC CLAIMED SHE BECAME AWARE OF THE ALLEGED ISSUE ON (B)(6) 2011. THE POCC REPORTED THERE WERE 3 (B)(6) HOSPITAL METERS ASSIGNED TO THE UNIT AND THE HOSPITAL METERS ARE PROGRAMMED TO LOCK OUT IF THEY DO NOT COMMUNICATE WITH THE DATALINK WORKSTATION IN A 96 HOUR PERIOD. THE POCC CLAIMED SHE DOWNLOADED THE METERS ASSIGNED TO THIS UNIT ON (B)(6) 2011. ON (B)(6) 2011 AT 1:30AM, THE POCC REPORTED THEY ATTEMPTED TO TEST THE BLOOD GLUCOSE OF A NEWBORN (B)(6) WHO WAS ADMITTED FOR AN "ENDOCRINE DISORDER". THE POCC REPORTED THAT THE PATIENT'S BLOOD GLUCOSE WAS KNOWN TO BE UNCONTROLLED AND THEIR BLOOD GLUCOSE WAS BEING TESTED HOURLY. IT IS NOT KNOWN WHAT THE PATIENT'S CONDITION WAS AT THE TIME THEY ATTEMPTED TO TEST HIS/HER BLOOD GLUCOSE. WHEN THEY ATTEMPTED TO TEST THE PATIENT THEY OBTAINED A MESSAGE ON THE METER OF "UPLOAD OVERDUE". THEY ATTEMPTED TO DOWNLOAD THE METERS FROM THEIR UNIT; HOWEVER, WHEN THEY WERE UNABLE TO DOWNLOAD THE METERS SUCCESSFULLY, THEY WENT TO A DIFFERENT UNIT. THE POCC CONFIRMED THE METERS WERE DOWNLOADED SUCCESSFULLY FROM A DIFFERENT UNIT. AT AN UNKNOWN TIME, THE POCC CLAIMED THE PATIENT WAS THEN TESTED WITH ONE OF THE METERS AND OBTAINED A READING OF "1.9 MMOL/L (34 MG/DL)". AT 1:52AM THE PATIENT WAS TREATED WITH IV DEXTROSE. DURING THE FOLLOW-UP CALL, THE POCC INFORMED THE MSS THAT THE COMMUNICATION ISSUE AT THE UNIT WITH THE SPECIFIC WORKSTATION HAD BEEN INTERMITTENT FOR AT LEAST A 3 MONTH PERIOD. THE POCC CONFIRMED THE COMMUNICATION ISSUE WAS RESOLVED WHEN THE COMPUTER AT THE UNIT (WHICH WAS NOT SUPPLIED BY LFS) WAS REPLACED BY THE FACILITIES IT DEPARTMENT. THE POCC REPORTED THAT THE COMMUNICATION MOTHERBOARD ON THE UNIT'S PC WAS NOT FUNCTIONING. ALTHOUGH THERE IS NO INDICATION OF A PRODUCT MALFUNCTION WITH THE (B)(6) HOSPITAL METER, THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT WAS TREATED FOR SEVERE HYPOGLYCEMIA AFTER THEY WERE REPORTEDLY UNABLE TO OBTAIN A BLOOD GLUCOSE READING WITH THE LFS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSP SS FLEXX METER W/O LASER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R