inforMED
MalfunctionCKD

REFLOTRON GPT (ALT)

Received Sep 25, 2006 · Event occurred Sep 11, 2006

Report 1823260-2006-05358 · MDR key 870187

Device

Generic name

Clinical Chemistry Test Strip

Manufacturer

Roche Diagnostics

Model number

NA

Catalog number

745138

Lot number

23719632

Product problems

  • Replace
  • Incorrect Or Inadequate Test Results

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE REPORTER CALLED AND ALLEGED DISCREPANT RESULTS ON THE DEVICE WHEN COMPARED TO A LAB FOR GPT. CONTROLS WERE REPORTED AS BEING IN RANGE AND THE SITE FAILED THEIR PROFICIENCY TEST AND DECIDED TO DO LAB COMPARISONS. THE COMPARISONS WERE DONE WHOLE BLOOD TO SERUM AND THEN SERUM TO SERUM. THE REPORTED DEVICE/LAB RESULTS WERE 11.4/12.0/26.0, 8.08/8.03/18.0, 9.44/9.56/22.0, 14.4/14.2/31.0 AND 9.66/9.29/19.0. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.