ACCESS® HLH REAGENT
Received Jun 7, 2011 · Event occurred May 11, 2011
Report 2122870-2011-01649 · MDR key 2115518
Device
Generic name
Human Luteinizing Hormone Assay
Manufacturer
Beckman Coulter, Inc.Catalog number
33510
Lot number
021773
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
METHOD: EVALUATION AND TROUBLESHOOTING ACTIVITIES WERE CONDUCTED VIA TELEPHONE. RESULT: ERRONEOUS DATA GENERATED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) TO REPORT ERRONEOUS "NO VALUE" RESULTS FOR LUTEINIZING HORMONE (LH) FOR FOUR PATIENT SAMPLES ASSAYED USING THE ACCESS HLH REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED PATIENT IMPACT. THE CUSTOMER REPORTED THAT QUALITY CONTROLS WERE ASSAYED EARLIER IN THE DAY PRIOR TO ASSAYING THE PATIENT SAMPLES. ALL QUALITY CONTROL RESULTS WERE WITHIN THEIR RESPECTIVE RANGES. THE CUSTOMER SUBSEQUENTLY INSERTED A FRESHLY OPENED HLH REAGENT PACK ONTO THE ACCESS 2 IMMUNOASSAY SYSTEM AND RE-ASSAYED THE FOUR PATIENT SAMPLES. NUMERICAL RESULTS WERE OBTAINED FOR EACH OF THE PATIENT SAMPLES AND ALL QUALITY CONTROL RESULTS WERE WITHIN THEIR RESPECTIVE RANGES. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT YET BEEN DETERMINED.