TRIAGE CARDIAC TRIPLE MARKER PANEL
Received Dec 11, 2015 · Event occurred Nov 19, 2015
Report 2027969-2015-01004 · MDR key 5290264
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97000HSLot number
W60020B
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
74 YR
- Syncope
- Low Blood Pressure/ Hypotension
- Renal Failure
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
COMPLAINT LOT W60020 WAS TESTED WITH CM CALIBRATOR J AND ALL TNI RESULTS WERE WITHIN 2SD OF THE EXPECTED VALUE AND PRODUCED A TNI CV OF 7.8%. THIS IS WITHIN THE PRODUCT INSERT CLAIM. LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD OF LOT W60020B. NO ISSUES WITH TNI RECOVERY OBSERVED. NO NCS OR TIFS WERE GENERATED DURING MANUFACTURING. LOT MET ALL FINAL RELEASE SPECIFICATIONS. THE RETURNED PATIENT SAMPLE WAS TESTED ON THE COMPLAINT CARDIAC LOT W60020B. BOTH DEVICES TESTED RESULTED IN A TNI OF <0.05 NG/ML. INSUFFICIENT RETURNED PATIENT SAMPLE VOLUME WAS PROVIDED TO PERFORM CONFIRMATORY TESTING. UNABLE TO CONFIRM THE CUSTOMER'S OBSERVED DISCREPANCY. NO PRODUCT DEFICIENCY WAS ESTABLISHED.
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: INVESTIGATION PENDING.
Description of Event or Problem
REPORT RECEIVED OF TNI LOW COMPARED TO VITROS; 1 PATIENT; TRIAGE=<0.05 X 2, VITROS=.132 AND 0.134 A (B)(6) FEMALE PRESENTED TO EMERGENCY DEPARTMENT WITH HYPOTENSION, ACUTE RENAL FAILURE AND SYNCOPE. FULL DRAW EDTA, NO SAMPLE QUALITY PROBLEMS, WAS TESTED FOR TNI AT <0.05 AT 12:14 PM, SN (B)(4), DLN W60020B. PHYSICIAN QUESTIONED THE RESULT AND A LITHIUM HEPARIN SAMPLE (FROM THE SAME COLLECTION) WAS TESTED ON THE LAB VITROS ANALYZER X 2 AT .132 AT 12:10 PM AND 0.134 AT 12:30 PM. NOTE FROM CUSTOMER'S (B)(6) EMAIL: "THE EMERGENCY DEPARTMENT STAFF RAN THE CARDIAC CARTRIDGE IN THE EMERGENCY DEPARTMENT AND THEY DID NOT USE THE PIPETTE TO LOAD THE CARTRIDGE. I PERSONALLY RERAN THE PATIENT IN THE LAB ON THE LAB'S TRIAGE METER THE PROPER WAY AND STILL GOT A TROPONIN OF <0.05 (AT 2:17 PM AS NOTED BELOW)" WHEN DISCREPANT RESULTS WERE OBTAINED, THE TECH WENT TO THE LAB AND OBTAINED THE CBC FROM THE SAME COLLECTION (TWO EDTAS DRAWN IN THE ED), TESTED AT <0.05 AT 2:17 PM IN THE LAB. TRIAGE TNI RANGE: <0.05 NORMAL, .05 - 0.2 INDETERMINATE, CRITICAL >0.2. VITROS TNI RANGE: 0-0.33 NORMAL. PATIENT HAD NOT BEEN DISCHARGED AS OF (B)(6) 2015. NO ADDITIONAL INFORMATION PROVIDED.