ELECSYS VITAMIN B12 II
Received Sep 1, 2021 · Event occurred Jul 26, 2021
Report 1823260-2021-02551 · MDR key 12408993
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Catalog number
07212771190
Lot number
54142701
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
Additional Manufacturer Narrative
CALIBRATION SIGNALS WERE SOMEWHAT HIGHER THAN EXPECTED. THIRD PARTY CONTROLS FLUCTUATED WITHIN TARGET RANGES FOR THE PERIOD OF (B)(6) 2021 AND VALUES HAD A TENDENCY OF BEING LOWER THAN THE TARGET. A FEW VALUES FOR EACH CONTROL LEVEL WERE OUTSIDE OF RANGE LOW. CONTROLS MANUFACTURED BY ROCHE RECOVERED WITHIN RANGE. THE CUSTOMER HAS STOPPED VITAMIN B12 TESTING. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
NA.
Description of Event or Problem
THE INITIAL REPORTER STATES SINCE THE MEASURING CELL HAS BEEN CHANGED, THEY HAVE BEEN GETTING LOWER QUALITY CONTROL AND PATIENT RECOVERY FOR THE ELECSYS VITAMIN B12 GEN. 2 IMMUNOASSAY ON THEIR COBAS E 411 IMMUNOASSAY ANALYZER. THE CUSTOMER RAN COMPARISON STUDIES USING PATIENT SAMPLES AND TESTED THESE ON THE E411 ANALYZER. THE SAMPLES WERE THEN SENT TO TWO DIFFERENT SITES, WHERE THEY WERE TESTED ON A SECOND E411 ANALYZER AND AN UNKNOWN COBAS 8000 SYSTEM (SERIAL NUMBERS UNKNOWN). OF THE REPEATED SAMPLES, TEN HAD RESULTS THAT WERE DISCREPANT. INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.