COBAS 6000 C501MODULE
Received Mar 17, 2011 · Event occurred Feb 24, 2011
Report 1823260-2011-01470 · MDR key 2022545
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745914001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE LDL-CHOLESTEROL PLUS 2ND GENERATION (LDL) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL LDL RESULT WAS 10 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S OTHER LIPID RESULTS WERE HIGH (TRIGLYCERIDE= 1799 MG/DL AND CHOLESTEROL= 244 MG/DL), THEREFORE, THE CUSTOMER SENT THE SAMPLE TO BE RETESTED AT AN OUTSIDE LABORATORY. THE SAMPLE WAS REPEATED ON AN UNSPECIFIED BECKMAN ANALYZER AND RECOVERED 178 MG/DL. THE CUSTOMER CONSIDERED THE RERUN VALUE OF 178 MG/DL TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED FOR THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE LDL REAGENT LOT NUMBER WAS 61704801. THE CUSTOMER DECLINED A FIELD SERVICE DISPATCH TO INVESTIGATE THE ISSUE BECAUSE SHE BELIEVED THE ISSUE WAS RELATED TO THE SAMPLE AND NOT THE ANALYZER.