ADVIA CHEMISTRY TRIGLYCERIDE METHOD
Received May 24, 2008 · Event occurred Feb 25, 2008
Report 2432235-2008-00060 · MDR key 1051308
Device
Generic name
Triglyceride Method
Manufacturer
Siemens Healthcare Diagnostics, Inc.Model number
NACatalog number
B01-4133-01
Lot number
RGT. LOT # 095939
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED A DISCORDANT TRIGLYCERIDE RESULT WHEN USING REAGENT LOT # 095939. THE SAMPLE INITIALLY READ 483 MG/DL AND UPON RETEST WITH A DILUTED SAMPLE, THE CORRECTED VALUE WAS 2120 MG/DL. THE CUSTOMER BECAME AWARE OF THIS PROBLEM WHEN SHE NOTICED THAT THE REACTION CURVE FOR THE INITIAL RESULT WAS DISCREPANT. THERE WAS NO PATIENT INTERVENTION AS A RESULT OF THIS DISCORDANT TRIGLYCERIDE RESULT.
Additional Manufacturer Narrative
DISCUSSIONS WITH THE OEM REAGENT MANUFACTURER INDICATES THAT THE ADVIA CHEMISTRY TRIGLYCERIDE METHOD KIT LOT 095939 IS EXHIBITING LOWER THAN EXPECTED LINEARITY. THE ROOT CAUSE. INVESTIGATION IS UNDER WAY BY THE MANUFACTURER.