FDA Adverse Event Malfunction Summary report: N

MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

MDR report key: 1111615 · Received August 13, 2008

Report

Report Number: 1056600-2008-00264
Event Type: Malfunction
Date Received: August 13, 2008
Date of Event: July 14, 2008
Report Date: August 13, 2008
Manufacturer: MICRO TYPING SYSTEMS, INC.
Product Code: KSZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TESTING PERFORMED ON THE PROVUE (USING A/B/D MONOCLONAL GROUPING CARD LOT NUMBER 121707053-09 AS WELL AS MANUALLY (USING MTS A/B/D REVERSE GROUPING CARD LOT NUMBER 030808037-26) AND ALSO MANUALLY WITH THE RETAINED GEL CARDS (LOT NUMBER 012308037-18 RESULTED IN A 2+ REACTION IN THE ANTI-D MICROTUBE. THE CUSTOMER TESTED THE PATIENT SAMPLE BY THE TRADITIONAL TUBE METHOD (ANTI-D MANUFACTURER NOT PROVIDED) AND REPORTED OBSERVING A 1-2+ REACTION AT THE WEAK D AHG PHASE OF TESTING. THE CUSTOMER CONFIRMED THE PATIENT TO BE WEAK D POSITIVE. NO DEFINITE ROOT CAUSE WAS DETERMINED FOR THE NEGATIVE RESULTS OBTAINED IN (B) (6) 2008 WITH THE PATIENT'S SAMPLE. THE IFU INDICATES THAT THE MTS MONOCLONAL ANTI-D GEL CARD MAY NOT DETECT VERY WEAK EXPRESSIONS OF THE D ANTIGEN. (B) (4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A PATIENT'S SAMPLE WAS INITIALLY TESTED AS D POSITIVE IN (B) (6) 2008 (GEL CARD LOT # 012308037-18). THE PATIENT WAS RECENTLY RE-TYPED IN (B) (6) 2008 AS D NEGATIVE USING THE SAME LOT OF GEL CARDS. THE CUSTOMER CONFIRMED IN TUBE METHOD THAT THE SAMPLE WAS WEAK D POSITIVE. A FALSE NEGATIVE RESULT IN ANTI-D MAY LEAD TO MISCLASSIFICATION OF A PATIENT'S RH PHENOTYPE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD	A/B/O & RH TYPE TESTING REAGENT	KSZ	MICRO TYPING SYSTEMS, INC.	NA	012308037-18

Patients

Seq	Age	Sex	Outcome	Treatment
1