1628664-2017-00376
Report
- Report Number
- 1628664-2017-00376
- Event Type
- Malfunction
- Date Received
- October 11, 2017
- Report Date
- October 11, 2017
- PMA / PMN Number
- K983212
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE CUSTOMER OBSERVED A SINGLE FALSELY ELEVATED AFP PATIENT RESULT ON ARCHITECT SERIAL NUMBER (B)(4). UPON SITE VISIT, THE ABBOTT FIELD SERVICE REPRESENTATIVE REPLACED THE WASH ZONE MANIFOLD VALVES FOR BOTH WASH ZONES 1 AND 2 (PART NUMBER 7-77612-03). A REVIEW OF THE ANALYZER SERVICE HISTORY DID NOT IDENTIFY ISSUES THAT MAY HAVE CONTRIBUTED TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE MANIFOLD KIT VALVES WERE REPLACED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKETS DID NOT IDENTIFY AN INCREASE IN COMPLAINTS RELATED TO FALSELY ELEVATED RESULTS AND NO TRENDS FOR THE REPORTED ISSUE. A REVIEW OF THE ARCHITECT SYSTEMS OPERATION MANUAL ADDRESSES THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC OR DISCREPANT RESULTS INCLUDING: WASH ZONE MANIFOLD LEAKING, INADEQUATE WASH BUFFER DISPENSE AT THE WASH ZONE, BUBBLES IN TUBING, SAMPLE INTEGRITY/PREPARATION. A REVIEW OF THE ARCHITECT AFP PACKAGE INSERT PROVIDES INFORMATION FOR ACCEPTABLE SAMPLES, SAMPLE HANDLING, EXPECTED RESULTS, AND PERFORMANCE CHARACTERISTICS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT SN (B)(4) NOR THE WASH ZONE MANIFOLD VALVES, PART 7-77612-03.
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT AFP RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL RESULT = 372.72 / RETEST = 1.82 /1.85. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |