BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5125476 · Received October 2, 2015

    Report

    Report Number
    1052693-2015-01836
    Event Type
    Death
    Date Received
    October 2, 2015
    Date of Event
    July 30, 2015
    Report Date
    October 2, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. BASED ON NDI'S INTERNAL TECHNICAL EXAMINATION OF THE ERROR CODES IN METER MEMORY, A TWO-DIGIT ERROR CODE IS AVAILABLE AND PROVIDES MORE SPECIFIC INFORMATION RELATED TO THE CAUSE OF THE METER ERROR. THE TWO-DIGIT ERROR CODE IN ALL OF THE RETURNED METERS WAS E-03, WHICH APPEARS IN THE METER DISPLAY AS "E-0" TO THE USER. THE E-03 ERROR INDICATES SPECIFICALLY THAT THE METER MEASURED A LOW HEMATOCRIT. AN E-03 (LOW HEMATOCRIT ERROR) CAN OCCUR IF THE BLOOD SAMPLE CONTAINS LOW HEMATOCRIT OR IF AN INCORRECT BLOOD SAMPLE (SUCH AS PLASMA) WAS USED. THESE 6 REPORTS (1052693-2015-01594, 1052693-2015-01595, 1052693-2015-01596, 1052693-2015-01597, 1052693-2015-01598, AND 1052693-2015-01836) ARE REPORTS FOR THE SAME SINGLE INCIDENT (COMPLAINT). BECAUSE THE EXACT METER INVOLVED IN THE INCIDENT COULD NOT BE IDENTIFIED BY THE COMPLAINANT, EACH OF THE 6 METERS IDENTIFIED IN THIS SINGLE COMPLAINT WERE REPORTED. BASED ON REVIEW OF ALL CORRESPONDENCES REGARDING THE COMPLAINT, WE CORRECTED THE DATE OF EVENT TO AN EARLIER DATE; THEREFORE, BASED ON THE REVISED DATE OF EVENT, THE ORIGINAL REPORTS WERE FILED AFTER THE REQUIRED 30 DAYS.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. BASED ON NDI'S INTERNAL TECHNICAL EXAMINATION OF THE ERROR CODES IN METER MEMORY, A TWO-DIGIT ERROR CODE IS AVAILABLE AND PROVIDES MORE SPECIFIC INFORMATION RELATED TO THE CAUSE OF THE METER ERROR. THE TWO-DIGIT ERROR CODE IN ALL OF THE RETURNED METERS WAS E-03, WHICH APPEARS IN THE METER DISPLAY AS "E-0" TO THE USER. THE E-03 ERROR INDICATES SPECIFICALLY THAT THE METER MEASURED A LOW HEMATOCRIT. AN E-03 (LOW HEMATOCRIT ERROR) CAN OCCUR IF THE BLOOD SAMPLE CONTAINS LOW HEMATOCRIT OR IF AN INCORRECT BLOOD SAMPLE (SUCH AS PLASMA) WAS USED. THESE 6 REPORTS (1052693-2015-01594, 1052693-2015-01595, 1052693-2015-01596, 1052693-2015-01597, 1052693-2015-01598, AND 1052693-2015-01836) ARE REPORTS FOR THE SAME SINGLE INCIDENT (COMPLAINT). BECAUSE THE EXACT METER INVOLVED IN THE INCIDENT COULD NOT BE IDENTIFIED BY THE COMPLAINANT, EACH OF THE 6 METERS IDENTIFIED IN THIS SINGLE COMPLAINT WERE REPORTED. BASED ON REVIEW OF ALL CORRESPONDENCES REGARDING THE COMPLAINT, WE CORRECTED THE DATE OF EVENT TO AN EARLIER DATE; THEREFORE, BASED ON THE REVISED DATE OF EVENT, THE ORIGINAL REPORTS WERE FILED AFTER THE REQUIRED 30 DAYS. THE PATIENT WAS ADMITTED TO THE FACILITY 25 HOURS BEFORE THIS INCIDENT. ACCORDING TO THE PATIENT'S HEALTH RECORD, THE PATIENT WAS HOSPITALIZED WITH A GASTROINTESTINAL BLEED AND A LOW HEMATOCRIT SEVERAL WEEKS BEFORE THIS ADMISSION, DURING WHICH HE HAD SURGERY TO REPAIR AN ABDOMINAL ANEURYSM. ADDITIONALLY, THE PATIENT SUFFERED A PULMONARY EMBOLISM AND WAS ON TPN DURING HIS STAY IN THE HOSPITAL. THE PATIENT HAD A HEMATOCRIT OF 8.7% PRIOR TO DISCHARGE FROM THE HOSPITAL. ONCE IN THE REHABILITATION FACILITY, HIS BLOOD PRESSURE AND PULSE WERE STABLE BUT HAD LOW PULSE OXIMETRY READINGS. WHEN THE PATIENT WAS DISCOVERED UNRESPONSIVE, THE LICENSED NURSE PERFORMED A FINGERSTICK BLOOD GLUCOSE TEST ON THE PATIENT. FURTHER INFORMATION OBTAINED FROM THE FACILITY INDICATED THAT AFTER RECEIVING AN E-0 ERROR MESSAGE ON THE PATIENT, THE NURSE PERFORMED THE TESTING ON HERSELF AT THE TIME OF THE EVENT. SHE OBTAINED AN ERROR MESSAGE (SHE COULD NOT RECALL WHICH ERROR MESSAGE) ON THE FIRST TWO TESTS AND ON THE THIRD TEST SHE OBTAINED A RESULT. THE ABOVE CONDITIONS REVEAL THE SEVERITY OF THE PATIENT'S ILLNESS, AND EXPLAIN WHY THE ERROR CODE E-0 WOULD BE THE READING FROM THE BLOOD GLUCOSE METER. THE PATIENT WAS PERFUSING POORLY, AND HAD A LOW HEMATOCRIT (8.7%) WHICH IS A TRIGGER FOR THE E-0 CODE. THIS FACILITY USED THE PRODUCT ON A PATIENT EXHIBITING A LIMITATION OF USE (HEMATOCRIT) THAT WE CLEARLY STATE IN OUR LABELING. BASED ON THIS INFORMATION, THE PRODUCT PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED METER IS READING E-0. RECEIVED EMAIL FROM (B)(6). (B)(6) STATES, "I HAD A RESIDENT IN OUT REHAB UNIT THAT WAS A DIABETIC THAT HAD RECENTLY HAD SURGERY. THIS PERSON BECAME NONRESPONSIVE LOOKED VERY PEAKED AND AS PROTOCOL AS A NURSE WE CHECK THE BLOOD SUGARS AS WELL AS ALL OTHER VITALS, ESPECIALLY A DIABETIC. I COULDN'T OBTAIN THE BLOOD SUGAR ANY WHICH WAY, WITH OR WITHOUT ALCOHOL, ON MYSELF, AND IT KEPT STATING E-0 (MULTIPLE TIMES). THIS RESIDENT WAS SENT TO HOSPITAL AND PASSED AWAY. I DON'T KNOW WHAT FROM, I DON'T THINK IT WAS FROM THE DIABETES BUT IN AN EMERGENCY I DON'T HAVE TIME TO WAIT. I HAVE GOTTEN IT TO WORK A TOTAL OF 3 TIMES OUT OF 15. THEY WORK WHEN THEY WANT TO AND THEY DON'T WANT TO FOR ME AND IF YOU ASK AROUND MULTIPLE STAFF HAVE HAD THE SAME ERROR OR THE ERROR E-3, MANY TIMES. THANKS"

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED METER IS READING E-0. RECEIVED EMAIL FROM (B)(6) STATES, "I HAD A RESIDENT IN OUT REHAB UNIT THAT WAS A DIABETIC THAT HAD RECENTLY HAD SURGERY. THIS PERSON BECAME NONRESPONSIVE LOOKED VERY PEAKED AND AS PROTOCOL AS A NURSE WE CHECK THE BLOOD SUGARS AS WELL AS ALL OTHER VITALS, ESPECIALLY A DIABETIC. I COULDN'T OBTAIN THE BLOOD SUGAR ANY WHICH WAY, WITH OR WITHOUT ALCOHOL, ON MYSELF, AND IT KEPT STATING E-0 (MULTIPLE TIMES). THIS RESIDENT WAS SENT TO HOSPITAL AND PASSED AWAY. I DON'T KNOW WHAT FROM, I DON'T THINK IT WAS FROM THE DIABETES BUT IN AN EMERGENCY I DON'T HAVE TIME TO WAIT. I HAVE GOTTEN IT TO WORK A TOTAL OF 3 TIMES OUT OF 15. THEY WORK WHEN THEY WANT TO AND THEY DON'T WANT TO FOR ME AND IF YOU ASK AROUND MULTIPLE STAFF HAVE HAD THE SAME ERROR OR THE ERROR E-3, MANY TIMES. THANKS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652831 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEMETRIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Death