ELECSYS VITAMIN B12 II
Received Aug 7, 2019 · Event occurred Jul 13, 2019
Report 1823260-2019-02890 · MDR key 8870890
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Catalog number
07212771190
Lot number
38496501
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED, SINCE CUSTOMER¿S QC WAS FOUND WITHIN THE SPECIFIED TARGET RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
A FIELD ENGINEERING SPECIALIST CHECKED THE SYSTEM AND FOUND NO ROOT CAUSE. QC RESULTS BEFORE AND AFTER THE DATE OF THE EVENT WERE ACCEPTABLE. THE INVESTIGATION IS CURRENTLY ONGOING. THE EVENT OCCURRED IN: (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR 1 PATIENT TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER COMPARED TO THE RESULTS FROM AN UNSPECIFIED METHOD IN ANOTHER LABORATORY. THE INITIAL (SAMPLE A) VITAMIN B12 RESULT WAS 210 PG/ML. THE PATIENT WAS TESTED IN ANOTHER LABORATORY ON THE SAME DAY ON AN UNSPECIFIED SYSTEM (SAMPLE B) AND HAD A VITAMIN B12 RESULT OF < 83 PG/ML. SAMPLE A WAS THEN SENT TO A DIFFERENT CUSTOMER ON (B)(6) 2019 AND HAD A VITAMIN B12 RESULT OF 83 PG/ML. SAMPLE A WAS AGAIN TESTED ON THE ORIGINAL ANALYZER AND HAD A RESULT OF 202 PG/ML. THE RESULTS IN QUESTION WERE REPORTED OUTSIDE OF THE LABORATORY. THE COBAS E411 SERIAL NUMBER IS (B)(4).