MalfunctionGKA
VARIANT NBS SICKLE CELL PROGRAM
Received Dec 16, 2013 · Event occurred Nov 19, 2013
Report 2915274-2013-00015 · MDR key 3724762
Device
Generic name
Abnomral Hemoglobin Quantitation
Manufacturer
Bio-rad Laboratories Inc.Catalog number
250-3000
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE FIELD SERVICE ENGINEER REPORTED A POTENTIAL RISK THAT AN ELUTED SAMPLE DISC THAT CAN ADHERE TO THE SAMPLE PROBE WHICH HAS BEEN SEEN DROPPED ONTO THE MICROPLATE AREA MAY DROP INTO AN UNSAMPLED WELL WHICH MAY CAUSE SAMPLE CONTAMINATION OF THE UNSAMPLED WELL AND POTENTIALLY AN INCORRECT RESULT.
Additional Manufacturer Narrative
STUDIES WILL BE PERFORMED AT BIO-RAD TO MEASURE ACTUAL IMPACT OF AN ELUTED DROPPED DISC INTO AN UNSAMPLED WELL.