FDA Adverse Event Malfunction Summary report: N

ACCESS® TOXO IGG

MDR report key: 2940036 · Received February 1, 2013

Report

Report Number: 2122870-2013-00071
Event Type: Malfunction
Date Received: February 1, 2013
Date of Event: October 22, 2012
Report Date: January 9, 2013
Manufacturer: BECKMAN COULTER
Product Code: LGD
PMA / PMN Number: K080869
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00070, 2122870-2013-00071, 2122870-2013-00072.

Description of Event or Problem · 1

THE AFFILIATE REPORTED THE CUSTOMER ALLEGED NON-REACTIVE TOXOPLASMA IMMUNOGLOBULIN G (IGG) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS TOXO IGG REAGENT, USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. RESULTS FROM SEPTEMBER, OCTOBER AND NOVEMBER 2012 WERE ALL NON-REACTIVE AND EACH SAMPLE PRODUCED A VALUE OF 1UI/ML. DUE TO THE DISCREPANCY, THE CUSTOMER REANALYZED ALL RETAINED SAMPLES FOR THE SAME PATIENT AND ALL SAMPLES WERE REACTIVE AND PRODUCED A VALUE OF 13 UI/ML. THE NON-REACTIVE RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED QUALITY CONTROL (QC), CALIBRATIONS, AND SYSTEM CHECKS WERE WITHIN THE ACCEPTABLE PERFORMANCE RANGE AT THE TIME OF THE EVENT. AN ALTERNATE TOXO IGG REAGENT LOT WAS USED TO ANALYZE THE SAME PATIENT SAMPLES AND ALL RESULTS WERE REACTIVE. PATIENT SAMPLES WERE NOT SUPPLIED FOR FURTHER ANALYSIS. THIS IS REPORT TWO OF THREE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
44698	ACCESS® TOXO IGG	ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII	LGD	BECKMAN COULTER	NA	292842

Patients

Seq	Age	Sex	Outcome	Treatment
1