ELECSYS CK-MB
Received Jul 6, 2022 · Event occurred Apr 25, 2022
Report 1823260-2022-01976 · MDR key 14937844
Device
Generic name
Colorimetric Method, Cpk Or Isoenzymes
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05894808190
Lot number
538371
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
Patient
5 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CK-MB IMMUNOASSAY VER. 4 ON A COBAS E 411 IMMUNOASSAY ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THREE TUBES WERE COLLECTED FROM THE PATIENT AT THE SAME TIME ON (B)(6) 2022, A SERUM SEPARATOR TUBE, A LITHIUM HEPARIN PLASMA TUBE, AND A PLAIN RED TOP TUBE. THERE WERE DIFFERENCES IN CK-MB RESULTS BETWEEN THE TUBES. THE SERUM SEPARATOR TUBE WAS TESTED TWICE ON (B)(6) 2022, RESULTING IN CK-MB VALUES OF 3.75 NG/ML AND 3.61 NG/ML. THE PLAIN RED TOP TUBE WAS TESTED THREE TIMES ON (B)(6) 2022, RESULTING IN CK-MB VALUES OF 14.50 NG/ML, 14.38 NG/ML, AND 14.62 NG/ML. THE LITHIUM HEPARIN PLASMA TUBE WAS TESTED ON (B)(6) 2022, RESULTING IN A CK-MB VALUE OF 5.93 NG/ML.
Additional Manufacturer Narrative
THE LAST CALIBRATION PERFORMED ON (B)(6) 2022 WAS WITHIN EXPECTATIONS. THE CALIBRATION INTERVAL HAS BEEN EXCEEDED. PER PRODUCT LABELING, RENEWED CALIBRATION IS RECOMMENDED AFTER 12 WEEKS WHEN USING THE SAME REAGENT LOT, AFTER 7 DAYS WHEN USING THE SAME REAGENT KIT ON THE ANALYZER OR AS REQUIRED. QUALITY CONTROLS TESTED BETWEEN (B)(6) 2022 AND (B)(6) -2022 WERE WITHIN RANGE. AN ISSUE WITH THE REAGENT IS UNLIKELY. THE CUSTOMER STATED THAT NO ABNORMAL FLAGGING OCCURRED DURING SAMPLE PROCESSING. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A PRE-ANALYTICAL HANDLING ISSUE COULD NOT BE RULED OUT.
Additional Manufacturer Narrative
THE RESULT OF 14.4 NG/ML FROM THE RED TOP TUBE WAS INITIALLY REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS THEN CORRECTED TO 3.8 NG/ML BASED ON THE VALUE FROM THE SERUM SEPARATOR TUBE. THE 3.8 NG/ML VALUE WAS CONCORDANT WITH THE HEPARIN TUBE RESULT AND WAS ALSO WITHIN THE NORMAL REFERENCE RANGE. THE PHYSICIAN MENTIONED THE PATIENT DID NOT SHOW ANY SYMPTOMS OF CARDIAC DISEASE. THE PATIENT'S TROPONIN T RESULT ALSO WAS WITHIN THE NORMAL REFERENCE RANGE. MEDWATCH FIELD D4. HAS BEEN UPDATED.