FDA Adverse Event Malfunction Summary report: N

GALILEO

MDR report key: 3820584 · Received May 20, 2014

Report

Report Number: 1034569-2014-00074
Event Type: Malfunction
Date Received: May 20, 2014
Date of Event: April 24, 2014
Report Date: May 19, 2014
Manufacturer: IMMUCOR, INC.
Product Code: KSZ
PMA / PMN Number: BK040013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELLS IMAGES: ANTI-B WELL 4+ POSITIVE, REACTION STRENGTH 95, VISUALLY CLOT IN CELL SUSPENSION CAUSING UNEXPECTED POSITIVE. NO ERRORS DURING PROCESSING, ALL OTHER SAMPLES RESULTED AS EXPECTED. ISSUE DETERMINED TO BE SAMPLE RELATED HOWEVER LIMITATION FROM OPERATOR MANUAL ALSO APPLIES: 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 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. VERY LARGE RED CELL CLOTS MAY NOT BE DETECTED BY THE GALILEO. CLOTS THAT INCLUDE GREATER THAN 50% OF THE SAMPLE RED BLOOD CELLS MAY NOT BE DETECTED BY THE INSTRUMENT. CLOTTED SAMPLES SHOULD NOT BE TESTED ON THE GALILEO.

Description of Event or Problem · 1

ON (B)(6) 2014, A CUSTOMER REPORTED AN ABO DISCREPANCY WHEN TESTING A SAMPLE ON THE GALILEO INSTRUMENT. NO ADVERSE REACTIONS OCCURRED AS A RESULT OF TEST RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
300287	GALILEO	AUTOMATED BLOOD BANK SYSTEM	KSZ	IMMUCOR, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1