ELECSYS VITAMIN B12 II
Received Jul 31, 2020 · Event occurred Jul 6, 2020
Report 1823260-2020-01850 · MDR key 10352271
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Catalog number
07212771190
Lot number
44583501
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER FOUND A BROWN MICROBEAD RING ON ONE OF THE AFFECTED REAGENT PACKS. BASED ON THE PROVIDED QC DATA, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE VITAMIN B12 G2 ELECSYS RESULTS FOR QC MATERIAL AND THREE PATIENT SAMPLES FROM COBAS E411 RACK ANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER REPLACED THE REAGENT, RECALIBRATED THE ASSAY AND REPEATED THE SAMPLES. SAMPLE 1 INITIAL RESULT WAS 135.9 PG/ML AND THE REPEAT RESULT WAS 348.2 PG/ML. SAMPLE 2 INITIAL RESULT WAS 118.4 PG/ML AND THE REPEAT RESULT WAS 227.7 PG/ML. SAMPLE 3 INITIAL RESULT WAS 195.6 PG/ML AND THE REPEAT RESULT WAS 301.7 PG/ML. IT WAS UNKNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A HANDLING ISSUE AT THE CUSTOMER SITE COULD NOT BE EXCLUDED AS THE CUSTOMER USES THE REAGENT KITS LONGER THAN THE SPECIFIED STABILITY AS PER PRODUCT LABELING. INAPPROPRIATE STORAGE/TRANSPORTATION CONDITIONS AT THE CUSTOMER SITE COULD NOT BE EXCLUDED BASED ON THE BROWN MICROBEAD RING VISIBLE ON ONE OF THE AFFECTED KITS. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED AS THE CUSTOMER QC DATA WAS WITHIN THE SPECIFIED RANGES.