COBAS 6000 C (501) MODULE
Received Oct 16, 2017 · Event occurred Aug 23, 2017
Report 1823260-2017-02312 · MDR key 6950879
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
C501Catalog number
ASKU
Lot number
NA
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AS THE SAMPLE HAD HIGH IGM, IT COULD NOT BE EXCLUDED THAT A MONOCLONAL GAMMOPATHY IS THE ROOT CAUSE FOR THE CUSTOMER'S ISSUE. ACCORDING TO PRODUCT LABELING, IGM GAMMOPATHY MAY CAUSE UNRELIABLE RESULTS. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE FOLLOWING MEDWATCH FIELDS HAVE BEEN UPDATED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6).
Description of Event or Problem
THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ALB2 ALBUMIN GEN.2 (ALB) ON A COBAS 6000 C (501) MODULE - C501. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE CLINICIANS. THE SAMPLE INITIALLY RESULTED AS < 10 AND REPEATED WITH A RESULT THAT WAS TWICE AS HIGH. THE UNITS OF MEASURED USED FOR THE ALB ASSAY WERE ASKED FOR, BUT NOT PROVIDED. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE ALB REAGENT LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED.