FDA Adverse Event Malfunction Summary report: N

ERYTYPE S RH+K TYPE

MDR report key: 2254833 · Received August 23, 2011

Report

Report Number: 9610824-2011-00109
Event Type: Malfunction
Date Received: August 23, 2011
Date of Event: July 12, 2011
Report Date: August 12, 2011
Manufacturer: BIO-RAD MEDICAL DIAGNOSTICS GMBH
Product Code: KSZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

STN# (B)(4). TESTING OF THE QUALITY CONTROL LAB CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF ERYTYPE S RH+K. A CHECK-UP OF THE TANGO INSTRUMENT LEAD TO THE CONVICTION THAT AN INSTRUMENT MALFUNCTION CAN BE EXCLUDED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT.

Description of Event or Problem · 1

THE CUSTOMER COMPLAINED ABOUT TWO DISCREPANT REACTIONS WITH THE ANTI-K REAGENTS ON ERYTYPE S RH+K ART.NO. (B)(4) LOT 1035010. CUSTOMER REPORTED THAT TWO SAMPLES REACTED NEGATIVELY WITH ANTI-K CLONE (B)(4). WHEN THE SAMPLES WERE RE-TESTED, THEY REACTED CORRECTLY NEGATIVE WITH BOTH ANTI-K REAGENTS (B)(4). CUSTOMER HAS SENT US THE PT SAMPLES AND THE ALLEGEDLY DEFECTIVE ERYTYPE S RH+K. SAMPLES WERE TESTED WITH THE ALLEGEDLY DEFECTIVE SAMPLE OR ERYTYPE S RH+K ON TANGO IN OUR QUALITY CONTROL LABORATORY. ALL SAMPLES REACTED CORRECTLY NEGATIVE WITH BOTH ANTI-K ON ERYTYPE S RH+K. THE SAMPLES WERE ALSO TESTED USING THE TUBE TECHNIQUE, BOTH WERE KELL NEGATIVE. WE ALSO TESTED FURTHER KELL NEGATIVE AND POSITIVE RED CELLS. ALL REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ERYTYPE S RH+K TYPE	ERYTYPE S RH+K TYPE	KSZ	BIO-RAD MEDICAL DIAGNOSTICS GMBH		1035010

Patients

Seq	Age	Sex	Outcome	Treatment
1				TANGO: SERIAL NO. (B)(4)