TRIAGE CARDIAC PANEL
Received Nov 20, 2014 · Event occurred Oct 24, 2014
Report 2027969-2014-01029 · MDR key 4292898
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
CUSTOMER'S COMPLAINT OF DISCREPANT LOW TNI WAS NOT OBSERVED DURING IN-HOUSE TESTING OF RETAIN LOW W57929. LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD FOR THE COMPLAINT LOT, NO NC'S OR RELATED TIF'S WERE GENERATED FOR THE LOT DURING PRODUCTION. PATIENT SAMPLE WILL NOT BE RETURNED, UNABLE TO RULE OUT SAMPLE SPECIFIC ISSUES. UNABLE TO DETERMINE THE ROOT CAUSE OF CUSTOMER COMPLAINT WITH THE GIVEN INFORMATION. PRODUCT DEFICIENCY WAS NOT ESTABLISHED WITH RETAIN TESTING. AS THERE IS NO INDICATION OF A PRODUCT DEFICIENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.
Description of Event or Problem
CALLER ALLEGING DISCREPANT LOW TNI 1X: TRIAGE CARDIAC LESS THAN OR EQUAL TO 0.05 AND ARCHITECT LAB ANALYZER = 0.366. REFERENCE RANGES: TRIAGE (B)(6) 2014, NEGATIVE: <0.05 NG/ML, INTERMEDIATE: 0.06 - 0.39 NG/ML, POSITIVE: >0.40 NG/ML, ARCHITECT: (B)(6) 2014, NEGATIVE: LESS THAN 0.022 NG/ML, INTERMEDIATE: 0.023 - 0.29 NG/ML, POSITIVE: GREATER THAN OR EQUAL TO 0.30 NG/ML. ON (B)(6) 2014 PATIENT ADMITTED TO HOSPITAL DIAGNOSIS CHF. DATE OF DISCHARGE (B)(6) 2014. DISCHARGE DIAGNOSIS CHF STAGE 4, HTN, FLUID OVERLOAD, CHF, DM. FU CARE JC-RENAL APPOINTMENT. NO TREATMENT WITHHELD BASED ON TRIAGE RESULTS.