ELECSYS HE4 ASSAY
Received Jan 18, 2022 · Event occurred Dec 24, 2021
Report 1823260-2022-00140 · MDR key 13284875
Device
Generic name
Epithelial Ovarian Tumor Associated Antigen (he4) Test
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05950929190
Lot number
533180
Product problems
- Low Test Results
- Low Readings
- Low Test Results
- Low Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 8 PATIENT SAMPLES TESTED FOR ELECSYS HE4 ASSAY (HE4) ON A COBAS 8000 E 602 MODULE. THE QUESTIONABLE RESULTS WERE FROM ONE PARTICULAR REAGENT PACK. THE REPEAT RESULTS WERE FROM THE SAME LOT NUMBER BUT A DIFFERENT REAGENT PACK. REFER TO ATTACHED DATA FOR THE RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E602 MODULE SERIAL NUMBER WAS (B)(4).
Additional Manufacturer Narrative
THE INITIAL QC RESULTS WERE OUTSIDE OF THE TARGET RANGE; THE REPEAT QC RESULTS WERE WITHIN THE TARGET RANGE. MICROBEADS WERE FOUND AGGLUTINATED ON THE LID OF THE REAGENT PACK IN QUESTION. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER CHANGED TO A DIFFERENT REAGENT PACK. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS THE REPEAT RESULTS FROM A DIFFERENT REAGENT PACK WITH THE SAME LOT NUMBER GAVE EXPECTED RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A TRANSPORTATION OR STORAGE ISSUE AFFECTING ONE PARTICULAR REAGENT PACK.
Additional Manufacturer Narrative
THE INITIAL QC RESULTS WERE OUTSIDE OF THE TARGET RANGE; THE REPEAT QC RESULTS WERE WITHIN THE TARGET RANGE. MICROBEADS WERE FOUND AGGLUTINATED ON THE LID OF THE REAGENT PACK IN QUESTION. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER CHANGED TO A DIFFERENT REAGENT PACK. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS THE REPEAT RESULTS FROM A DIFFERENT REAGENT PACK WITH THE SAME LOT NUMBER GAVE EXPECTED RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A TRANSPORTATION OR STORAGE ISSUE AFFECTING ONE PARTICULAR REAGENT PACK.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 8 PATIENT SAMPLES TESTED FOR ELECSYS HE4 ASSAY (HE4) ON A COBAS 8000 E 602 MODULE. THE QUESTIONABLE RESULTS WERE FROM ONE PARTICULAR REAGENT PACK. THE REPEAT RESULTS WERE FROM THE SAME LOT NUMBER BUT A DIFFERENT REAGENT PACK. REFER TO ATTACHED DATA FOR THE RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E602 MODULE SERIAL NUMBER WAS (B)(4).