FDA Adverse Event Malfunction Summary report: N

GALILEO

MDR report key: 916549 · Received September 21, 2007

Report

Report Number: 1034569-2007-00239
Event Type: Malfunction
Date Received: September 21, 2007
Date of Event: August 27, 2007
Report Date: September 20, 2007
Manufacturer: IMMUCOR, INC.
Product Code: KSZ
PMA / PMN Number: BK040013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

CONFIRMED THE PRESENCE OF THE JKA ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (CRRS), LOT X204 AND RETURNED AND RETENTION CRRS, LOT X207. CUSTOMER SENT SAMPLES FOR INVESTIGATION TESTING. 2_CELL TESTING PERFORMED ON IN-HOUSE GALILEO WITH RETENTION CRRS, LOTS X204 AND X207. SAMPLE WAS NONREACTIVE WITH CELLS I AND II [BOTH JK(A+B+)] FROM LOT X204 AND CELL II [JK(A+B+)] FROM LOT X207 AND EXHIBITED 1+ REACTIVITY WITH CELL I [JK(A+B-)] FROM LOT X207. ANOTHER SAMPLE EXHIBITED 3+ TO 4+ REACTIVITY WITH ALL JK(A+) CELLS.MANUAL TUBE TESTING WAS PERFORMED WITH SAMPLES 625708 AND 801983 USING A JK(A+B-) CELL (CELL II) FROM PANOSCREEN, LOT 29085 AND IMMUADD AS POTENTIATOR. SAMPLE 625078 EXHIBITED VERY WEAK MICROSCOPIC REACTIVITY AND SAMPLE 801983 EXHIBITED 1+ REACTIVITY AT THE ANTIGLOBULIN PHASE OF TESTING.A SERVICE CALL WAS PERFORMED. AN ADJUSTMENT WAS MADE TO PULSE TIME AND FLOW RATE ON ALL FOUR PUMPS. FOLLOWING ADJUSTMENTS, THE SYSTEM WAS TESTED AND OPERATED WITHIN SPECIFICATION.

Description of Event or Problem · 1

CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE USING THE 2_CELL SCREEN ASSAY ON GALILEO. THE SAMPLE WAS TESTED ON ANOTHER GALILEO; POSTIIVE REACTIONS WERE OBSERVED. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND POSITIVE REACTIONS WERE OBSERVED ON BOTH INSTRUMENTS.

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