MTS DILUENT 2 PLUS
Received Sep 4, 2008 · Event occurred Aug 6, 2008
Report 1056600-2008-00278 · MDR key 1156266
Device
Generic name
Red Blood Cell Diluent
Manufacturer
Micro Typing Systems, Inc.Model number
NACatalog number
MTS9325
Lot number
012-189
Product problems
- False Positive Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE POSITIVE RESULTS WITH THE MTS A/B/D MONOCLONAL, AND REVERSE GROUPING CARD LOT # 101007037-27, WITH 2 PATIENT SAMPLES. THE CUSTOMER INDICATED THE PATIENTS WERE TYPED AS GROUP A POSITIVE, WITH THE ANTI-B AND CONTROL MICROTUBES APPEARING AS WEAKLY POSITIVE REACTIONS. THE CUSTOMER SUSPECTED THE MTS DILUENT 2 PLUS LOT # 012-189 USED IN PREPARATION OF THE CELL SUSPENSIONS WAS CONTAMINATED. NO ERRONEOUS RESULTS WERE REPORTED.
Additional Manufacturer Narrative
IT IS UNK HOW THE DILUENT BECAME CONTAMINATED. THE CUSTOMER INDICATED THEY OBTAINED ACCEPTABLE RESULTS WHEN THE SAMPLES WERE REPEATED USING THE SAME LOT OF GEL CARDS, AND A NEWLY OPENED DILUENT BOTTLE FROM THE SAME LOT. THE CUSTOMER ALSO INDICATED THAT THE DISPENSER, THAT WAS PREVIOUSLY INVOLVED IN TESTING, WAS NOT USED DURING REPEAT TESTING. THEREFORE, CONTAMINATED DISPENSER MAY HAVE CONTRIBUTED TO THIS INCIDENT. REVIEW OF MANUFACTURING DOCUMENTS INDICATES THAT THIS PRODUCT PASSED ALL RELEASE CRITERIA. THE CUSTOMER DID NOT REPORT OF PARTICULATES OR ANY ABNORMAL APPEARANCE IN THE DILUENT BOTTLE PRIOR TO USE. A COMPLAINT REVIEW INDICATED NO OTHER COMPLAINTS HAVE BEEN LOGGED AGAINST THIS LOT OF DILUENT. INCIDENT IS ISOLATED. (B) (4).