ELECSYS VITAMIN B12 II
Received Apr 22, 2020
Report 1823260-2020-90041 · MDR key 9986270
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Lot number
39666302
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- Test Result
- Test Result
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOW UP ACTION FOR THE EVENT WAS THAT THE REAGENT KIT WAS REPLACED. AFTERWARDS, THE ISSUE WAS RESOLVED. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES MALFUNCTION EVENT. LOW RESULTS WERE GENERATED BY THE ELECSYS VITAMIN B12 IMMUNOASSAY ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENT INVOLVED A TOTAL OF 1 PATIENT. THE PATIENT'S AGE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED BUT WAS NOT PROVIDED.