BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSP SS FLEXX METER

    MDR report key: 1998293 · Received February 22, 2011

    Report

    Report Number
    2939301-2011-01551
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 510(K) # IS K081019. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE POINT OF CARE COORDINATOR (POCC) AT A HOSPITAL CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT A ONETOUCH SURESTEP FLEXX HOSPITAL METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE HEALTH CARE PROFESSIONAL AT THE LAB. THE HCP REPORTED THAT ON (B)(6) 2011 BETWEEN 11AM AND 11:30AM A PATIENT HOSPITALIZED IN THE FACILITY (FOR GASTRIC CARCINOMA) DEVELOPED SYMPTOMS OF "HYPERTENSION, UNRESPONSIVENESS" AND HAD A LOW HEART RATE. THE HCP STATED THAT PATIENT WAS NOT OPENING HER EYES OR RESPONDING TO PAIN STIMULI. IN RESPONSE TO THE SYMPTOMS, AT 12:02PM, THE PATIENT WAS TESTED WITH THE SUBJECT METER AND A RESULT OF "12.3 MMOL/L (221 MG/DL)" WAS OBTAINED. A LAB SAMPLE WAS OBTAINED AT THE SAME TIME AND THE RESULT CAME BACK AT "7.8 MMOL/L (140 MG/DL)". THE HCP STATED THAT THE PATIENT IS ON INSULIN AND THE INSULIN DOSE IS ADJUSTED ACCORDING TO THE PATIENT'S CONDITION. IN RESPONSE TO THE "12.3 MMOL/L" RESULT, IT WAS REPORTED THAT THE PATIENT WAS ADMINISTERED 2 UNITS OF HUMULIN THROUGH AN INFUSION. THE HCP REPORTED THAT THE PATIENT CONTINUED TO REMAIN UNRESPONSIVE AFTER BEING ADMINISTERED THE INSULIN, BUT CLAIMED HER HEALTH CONDITION DETERIORATED. HE STATED THAT SOMETIME AFTER THE INSULIN WAS ADMINISTERED THE PATIENT'S PUPILS WERE DILATED AND DID NOT RESPOND TO LIGHT. AT 2:30PM THAT SAME AFTERNOON, THE PATIENT'S BLOOD GLUCOSE WAS RE-TESTED AND THE HCP STATED THAT THEY OBTAINED A RESULT OF "0 MMOL/L" WITH THE SUBJECT METER. A LAB SAMPLE WAS OBTAINED AT THE SAME TIME AND AT 3:00PM THE RESULT CAME BACK AS "LESS THAN 1 MMOL/L". AT THE TIME OF THE LOW BLOOD GLUCOSE RESULTS, IT WAS REPORTED THAT THE PATIENT CONTINUED TO BE "UNRESPONSIVE" AND DEVELOPED ARRHYTHMIA. THE HCP REPORTED THAT THE PATIENT WAS TREATED WITH DEXTROSE AND WATER. THE REPORTER ALSO CONFIRMED THAT THE PATIENT RESPONDED TO THE TREATMENT AND AT A LATER TIME OPENED HER EYES. AT 4:00PM THAT AFTERNOON THE PATIENT OBTAINED A RESULT OF "9.5 MMOL/L" WITH THE SUBJECT METER. AT 5:39PM SHE WAS TESTED ON BOTH METER AND LAB. THE METER RESULT WAS "5.6 MMOL/L" AND LAB RESULT WAS "5.1 MMOL/L(B)(6). AT THE TIME OF TROUBLESHOOTING, THE TSR WAS TOLD BY THE HCP THAT THE PATIENT'S HEMATOCRIT WAS 22%, WHICH IS OUTSIDE OF THE SUBJECT METER'S SPECIFICATION (25-60%). THE TSR INFORMED THE HCP THAT VERY LOW HEMATOCRIT (LESS THAN 25%) MAY CAUSE INACCURATE HIGH RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD TO BE TREATED WITH DEXTROSE AND WATER, AFTER HER INSULIN DOSAGE WAS ADJUSTED BASED ON THE ALLEGED INACCURATE RESULT OBTAINED ON THE LFS METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R