FDA Adverse Event Malfunction Summary report: N

BECKMAN COULTER LAB AUTOMATION SYSTEM

MDR report key: 2122561 · Received June 14, 2011

Report

Report Number: 2050012-2011-02272
Event Type: Malfunction
Date Received: June 14, 2011
Date of Event: May 16, 2011
Report Date: May 19, 2011
Manufacturer: BECKMAN COULTER BIOMEDICAL GMBH
Product Code: JQP
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PER RECOMMENDATION OF BECKMAN COULTER INC. AND UPON CONCURRENCE BY CUSTOMER, A SECONDARY LABEL BARCODE READER IS SCHEDULED TO BE INSTALLED ON THE AUTOMATE 2500 S3I. THE PURPOSE OF THE SECONDARY BAR CODE READER IS TO IDENTIFY MISLABELED TUBES, TO PREVENT FURTHER PROCESSING.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A SECONDARY ALIQUOT TUBE WAS DOUBLE LABELED WITH TWO UNIQUE IDENTIFICATION CODES. BARCODE LABEL #(B)(4) WAS INCORRECTLY ADDITIONALLY APPLIED TO ALIQUOT TUBE # (B)(4). ON (B)(6) 2011, THE AUTOMATE 2500 S3I GENERATED A LABEL ERROR MESSAGE, HOWEVER, THE OPERATOR WAS UNABLE TO LOCATE A DETACHED LABEL AND RESUMED OPERATION. SUBSEQUENTLY, THE DETACHED LABEL FOR WHICH THE SYSTEM ALARM WAS GENERATED, AFFIXED ITSELF TO A SECONDARY ALIQUOT TUBE WHICH ALREADY POSSESSED A BARCODE. UPON SHIPPING DISPATCH, THE DOUBLE LABELED TUBE WAS FOUND WHEN THE IDENTIFICATION NUMBER WAS RECORDED AND IDENTIFIED AS A DUPLICATE TO AN ALIQUOT TUBE THAT HAD BEEN PREVIOUSLY SHIPPED. THE DOUBLE LABELED TUBE WAS NOT RELEASED FORM THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT IMPACT ATTRIBUTED OR ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BECKMAN COULTER LAB AUTOMATION SYSTEM	LAB AUTOMATION	JQP	BECKMAN COULTER BIOMEDICAL GMBH	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1