ELECSYS CMV IGG
Received Apr 26, 2022 · Event occurred Mar 1, 2022
Report 1823260-2022-01184 · MDR key 14208719
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027117190
Lot number
56805401
Product problems
- High Test Results
- Low Test Results
- High Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGG RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT HAD TWO SAMPLES COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S SAMPLES WERE REPEATED ON A VIDAS ANALYZER AND A LIAISON ANALYZER. ON (B)(6) 2022, THE PATIENT'S FIRST SAMPLE WAS COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULT WAS 2.5 U/ML POSITIVE. THE PATIENT'S VIDAS CMV IGG RESULT WAS 0.135 UA/ML NEGATIVE. ON (B)(6) 2022, THE PATIENT'S SECOND SAMPLE WAS COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULT WAS "<1" U/ML NEGATIVE. THE PATIENT'S VIDAS CMV IGG RESULT WAS 19 UA/ML POSITIVE. THE PATIENT'S LIAISON CMV IGG RESULT WAS 63 U/ML POSITIVE.
Additional Manufacturer Narrative
THE PATIENT'S SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.