FDA Adverse Event Malfunction Summary report: N

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

MDR report key: 2202781 · Received August 11, 2011

Report

Report Number: 2122870-2011-02859
Event Type: Malfunction
Date Received: August 11, 2011
Date of Event: May 26, 2011
Report Date: July 12, 2011
Manufacturer: BECKMAN COULTER INC.
Product Code: DHA
PMA / PMN Number: K023764
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SAMPLE WAS COLLECTED IN A SST TUBE. CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. PER CUSTOMER COMPLAINT, THE LABORATORY PROTOCOL IS TO REPEAT ALL TBHCG RESULTS <50MLU/ML. THE CUSTOMER IS MONITORING TBHCG "FLIERS" BY DOCUMENTING THE NON-REPRODUCIBLE RESULTS, SAMPLE TYPE, TUBE LOT NUMBERS AND WHAT CLINIC OR WARD THE SAMPLE WAS OBTAINED FROM. NO PATTERNS HAVE BEEN FOUND. QC HAS BEEN WITHIN THE CUSTOMER'S RANGES, NO HARDWARE ISSUES, AND NO OTHER ASSAYS ARE BEING QUESTIONED AT THIS TIME. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING NEGATIVE TOTAL BETA - HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULTS OUTSIDE OF THE ASSAYS PRECISION CLAIMS FOR ONE (1) PATIENT'S SAMPLE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS, PROVIDED BY THE CUSTOMER, ARE SHOWN. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	DHA	BECKMAN COULTER INC.	DXI 800	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1