ALIQUOTING ACCESSORY UPGRADE KIT
Received Jun 29, 2021 · Event occurred Jun 16, 2021
Report 2050012-2021-00041 · MDR key 12089339
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman CoulterModel number
ALIQUOTING ACCESSORY UPGRADE KITCatalog number
6605574
Product problems
- False Positive Result
- False Positive Result
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE DEVICE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE VALVE OF THE ALIQUOTTER NOZZLE ASSEMBLY TO RESOLVE THE ISSUE. NO FURTHER INFORMATION WAS AVAILABLE TO BE PROVIDED FOR THE DELAY IN PATIENT TREATMENT. BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4). NO PATIENT DEMOGRAPHIC INFORMATION (AGE, GENDER, WEIGHT, RACE OR ETHNICITY) WAS PROVIDED.
Description of Event or Problem
CUSTOMER REPORTED FALSE POSITIVE HCG (HUMAN CHORIONIC GONADOTROPIN) RESULTS GENERATED ON THE DXI DUE TO AN ALIQUOTER ISSUE ON THE AUTOMATION LINE CAUSING CROSS-CONTAMINATION OF THE SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. THE PATIENT TREATMENT WAS DELAYED DUE TO THE FALSE POSITIVE RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE DELAYED PATIENT TREATMENT.