ELECSYS VITAMIN B12 II
Received Dec 6, 2024 · Event occurred Nov 16, 2024
Report 1823260-2024-03568 · MDR key 20867912
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
79232203
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE E602 MODULE SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS 8000 E 602 MODULE. THE INITIAL RESULT WAS < 50 PG/ML WITH A DATA FLAG. THE INSTRUMENT AUTOMATICALLY REPEATED THE SAMPLE WITH A RESULT OF 691.5 PG/ML. ON (B)(6) 2024 THE CUSTOMER REPEATED THE SAMPLE WITH A RESULT OF 617.2 PG/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
CALIBRATION SIGNALS WERE HIGHER THAN EXPECTED. QC WAS ACCEPTABLE. "ABNORMAL SAMPLE ASPIRATION", "ABNORMAL ASPIRATION (SAMPLE PROBE)" AND "ABNORMAL SAMPLE PROBE MOVEMENT" ALARMS WERE OBSERVED ON THE ALARM TRACE DATA FROM (B)(6) 2024 AND (B)(6) 2024. THESE ALARMS SUGGEST SAMPLE QUALITY ISSUES. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.