B2MG TINA-QUANT BETA2-MICROGLOBULIN
Received Apr 25, 2019
Report 1823260-2019-90113 · MDR key 8551517
Device
Generic name
Beta-2-microglobulin Immunological Test System
Manufacturer
Roche DiagnosticsModel number
B2MGLot number
356659
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
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE WAS SOLVED BY REPLACEMENT OF THE REAGENT PACK. THE FOLLOW UP/CORRECTIVE ACTION WAS THE REAGENT PACK WAS REPLACED. 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 <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY A COBAS 6000 C (501) MODULE. THE EVENTS INVOLVED 1 PATIENT WITH DISCREPANT RESULTS FOR B2MG TINA-QUANT BETA2-MICROGLOBULIN. THE PROVIDED PATIENT'S AGE WAS (B)(6). THE PATIENT WAS A FEMALE.