FDA Adverse Event Malfunction Summary report: N

GALILEO

MDR report key: 1012812 · Received March 17, 2008

Report

Report Number: 1034569-2008-00067
Event Type: Malfunction
Date Received: March 17, 2008
Date of Event: February 20, 2008
Report Date: March 10, 2008
Manufacturer: IMMUCOR, INC.
Product Code: KSZ
PMA / PMN Number: BK040013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT IMAGES WERE REVIEWED AND APPEARED AS EXPECTED. TESTING PERFORMED WITH RETENTION ANTI-A, LOT 101673,101674 WITH IN HOUSE DONOR SAMPLES REVEALED TYPE A RED CELL STICKING IN THE ANTI-A WELLS. TO PREVENT THE STICKING, IN HOUSE STUDIES FOUND THAT PIPETTING THE REAGENTS INTO THE WELLS BEFORE THE SAMPLE RED CELLS GREATLY REDUCED THE STICKING. IN HOUSE COMPARISON TESTING OF THE NEW REAGENT-FIRST PIPETTING ORDER TO THE EXISTING SAMPLE-FIRST PIPETTING ORDER SHOWED NO UNEXPECTED NEGATIVE ANTI-A REACTIONS WITH THE NEW PIPETTING ORDER. SOME UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED DURING TESTING WITH THE CURRENT ASSAY. CUSTOMERS WERE NOTIFIED OF THE MODIFICATION TO THE ASSAY ON 9/20/07. THIS FACILITY DID HAVE THE MODIFIED ABO ASSAY SOFTWARE INSTALLED.ACCORDING TO THE GALILEO OPERATOR MANUAL,FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF THE REVERSE TYPE RESULTS. HAZARDOUS MISTYPES MAY OCCUR, SUCH AS AN A SAMPLE BEING INTERPRETED AS A GROUP AB, OR AN RH (D) NEGATIVE SAMPLE BEING INTERPRETED AS RH(D) POSITIVE. FOR THIS REASON, ABO-RH RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR'S HISTORY.

Description of Event or Problem · 1

CUSTOMER REPORTED AN ABO MISTYPE WHEN PROCESSING FWD-ABO ASSAY ON THE GALILEO. THE DONOR TYPED AS A O+ ON THE GALILEO; IN TUBE TESTING, THE DONOR TYPED AS A A+

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GALILEO	AUTOMATED BLOOD BANK ANALYZER	KSZ	IMMUCOR, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1