TRUE METRIX

Report

Report Number: 1052693-2015-01595
Event Type: Death
Date Received: September 3, 2015
Date of Event: July 30, 2015
Report Date: October 23, 2015
Manufacturer: NIPRO DIAGNOSTICS, INC.
Product Code: NBW
PMA / PMN Number: K140100
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

INTERNAL REPORT #(B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: PLASMA USED AS SAMPLE OR LOW HEMATOCRIT.

Additional Manufacturer Narrative · 1

(MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) CORRECTED PRODUCT RETURN AND ADDITIONAL MANUFACTURER NARRATIVE TO SHOW PRODUCT WAS NOT RETURNED. (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. 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.

Additional Manufacturer Narrative · 1

(MANUFACTURER NARRATIVE = F, CORRECTED DATA = T) CORRECTED PRODUCT RETURN AND ADDITIONAL MANUFACTURER NARRATIVE TO SHOW PRODUCT WAS NOT RETURNED. ORIGINAL (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. 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 = T) CORRECTED DATE OF EVENT AS (B)(6) 2015. ORIGINAL REPORT #1303077. RETURNED METER EVALUATED WITH NO DEFECT 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 = F, CORRECTED DATA = T) CORRECTED DEVICE AVAILABLE FOR EVALUATION, EVALUATION CODES AND ADDITIONAL MANUFACTURER NARRATIVE TO SHOW PRODUCT WAS RETURNED. THE WRITER OF REPORTS FOR FOLLOWUPS #2 AND 3 MISTAKENLY PROVIDED INCORRECT INFORMATION ABOUT THE RETURN OF THE PRODUCT. THE EVALUATION CODES PROVIDED WITH THE REPORT DATED 10/02/2015 WERE CORRECT. THE EVALUATION CODES HAVE BEEN CORRECTED BACK TO THE EVALUATION CODES IN THE REPORT DATED 10/02/2015 IN THIS FOLLOWUP REPORT (#4). ORIGINAL REPORT (B)(4). 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.