SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
Received Nov 23, 2011 · Event occurred Jul 11, 2011
Report 2050012-2011-07961 · MDR key 2346704
Device
Generic name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Manufacturer
Beckman Coulter, Inc.Model number
PHOSPHORUS REAGENTCatalog number
A09426
Lot number
M010604
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER CALLED ON (B)(6) 2011 TO REPORT THAT THE UNICEL DXC 600 SYNCHRON SYSTEM GENERATED FALSELY LOW PATIENT RESULTS. CUSTOMER STATED THAT THERE WERE PRECISION AND ACCURACY ISSUES WITH THE PHOSPHORUS (PHS) ASSAY, LOT #M010604. THE FIELD SERVICE ENGINEER (FSE) ORDERED A COLLAR WASH TO ADDRESS THE ISSUE. ON (B)(4) 2011, THE FSE REPLACED THE CARTRIDGE CHEMISTRY SAMPLE PROBE AND COLLAR WASH, AND THEN RAN PRECISION AND CORRELATION TESTS BETWEEN THE TWO DXC INSTRUMENTS IN THE LABORATORY. BOTH UNITS WERE CORRELATING AND WERE WITHIN SPECIFICATIONS. HOWEVER, CUSTOMER CONTINUED TO HAVE PHS ISSUES AS THE QUALITY CONTROL RECOVERY WAS LOW. THE CUSTOMER TECHNICAL SPECIALIST (CTS) SENT A REPLACEMENT SYRINGE AND A T-VALVE TO ADDRESS THE ISSUE. ON (B)(4) 2011, THE FSE REPLACED THE REAGENT WITH A NEW PHS REAGENT LOT, WHICH APPEARS TO HAVE RESOLVED THE ISSUE. CUSTOMER STATED THAT PATIENT TREATMENT WAS NOT AFFECTED AS THE RESULTS WERE AMENDED PRIOR TO TREATMENT. CUSTOMER NO LONGER HAS ACCESS TO THE PATIENT DATA FROM (B)(6) 2011.
Additional Manufacturer Narrative
(B)(4).