ACCESS® 2 IMMUNOASSAY SYSTEM
Received Jul 12, 2011 · Event occurred May 18, 2011
Report 2122870-2011-02244 · MDR key 2158361
Device
Generic name
Discrete Photometric Chemistry Analyzer For Clinical Use
Manufacturer
Beckman Coulter Inc.Model number
N/ACatalog number
81600N
Lot number
N/A
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBTAINING REPRODUCIBLE CYTOMEGALOVIRUS IMMUNOGLOBULIN G (CMV-IGG) RESULT FOR ONE (1) PATIENT ON (B)(6) 2011. ALL RESULTS WERE GENERATED BY THE LAB'S ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LAB. SUBSEQUENT TESTING OF THE SAMPLE ON AN ALTERNATE METHODOLOGY PRODUCED A DISCORDANT, NON REACTIVE RESULT. PATIENT RESULTS ARE PROVIDED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.
Additional Manufacturer Narrative
(B)(4). SPECIFY (B)(6) FOR OCCUPATION.
Additional Manufacturer Narrative
SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER, CMV-IGG QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK PERFORMED ON (B)(6) 2011 PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BEC CUSTOMER PRODUCT LINE SUPPORT (CPSL) TESTING OF PATIENT'S SAMPLE INDICATE THAT SAMPLE WAS REACTIVE FOR CMV-IGG. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.