ERYTYPE S RH+K TYPE

MDR report key: 4764407 · Received May 12, 2015

Report

Report Number: 9610824-2015-00017
Event Type: Malfunction
Date Received: May 12, 2015
Date of Event: April 13, 2015
Report Date: May 12, 2015
Manufacturer: BIO-RAD MEDICAL DIAGNOSTICS GMBH
Product Code: KSZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A PATIENT SAMPLE YIELDED A FALSE POSITIVE REACTION WITH ANTI-K OF ERYTYPE S RH+K TYPE ON TANGO OPTIMO. IN SEVERAL REPEATED TESTINGS THIS PATIENT SAMPLE YIELDED CORRECT RESULTS WITH ANTI-K. IN ONE CASE THE PATIENT SAMPLE SHOWED A +/- REACTION WITH THE NEGATIVE CONTROL OF ERYTYPE S RH+K TYPE INSTEAD OF A CLEAR NEGATIVE REACTION. THE CUSTOMER DID RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT, BUT THE SUPPOSEDLY DEFECTIVE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE AND ADDITIONAL DONOR SAMPLES ON QC'S RETAINED ERYTYPE S RH+K TYPE SAMPLE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. THE PATIENT SAMPLE YIELDED A CORRECT NEGATIVE REACTION WITH ANTI-K AND THE NEGATIVE CONTROL OF ERYTYPE S RH+K TYPE ON TANGO OPTIMO. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED: THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K TYPE FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
309379	ERYTYPE S RH+K TYPE	ERYTYPE S RH+K TYPE	KSZ	BIO-RAD MEDICAL DIAGNOSTICS GMBH		8412090

Patients

Seq	Age	Sex	Outcome	Treatment
1				BROMELIN FOR ERYTYPE, LOT 844714000