ELECSYS VITAMIN B12 II
Received Jul 25, 2024 · Event occurred Jul 2, 2024
Report 1823260-2024-02166 · MDR key 19829673
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
76500602
Product problems
- Low Test Results
- Low Test Results
Patient
65 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL B12 RESULT WAS 126.4 PG/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE APPROXIMATELY 155 PG/ML AND 165 PG/ML. AN ALIQUOT OF THE SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED ON A SIEMENS ANALYZER AND THE B12 RESULT WAS 224 PG/ML.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
IT WAS FOUND THAT THE CUSTOMER ONLY CENTRIFUGES PATIENT SAMPLES FOR 5 MINUTES, WHICH IS TOO SHORT. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) PERFORMED PERIODIC MAINTENANCE ON THE ANALYZER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.