TOSOH AIA ST VITAMIN D PRETREATMENT
Received Oct 3, 2014 · Event occurred Sep 18, 2014
Report 3005529799-2014-00015 · MDR key 4172255
Device
Generic name
Aia Vitamin D Pretreatment
Manufacturer
Tosoh Aia, Inc.,Model number
N/ACatalog number
025734
Lot number
E50B711
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(6), 2014 CUSTOMER TESTED APPROXIMATELY 100 SPECIMENS FOR VARIOUS IMMUNOS ASSAYS ON THE TOSOH AIA-2000. IT WAS NOTED THAT MANY OF THE VITAMIN D SPECIMENS HAD RESULTS <4.0 NG/ML. THREE SPECIMENS REPEATED AND RESULTS WERE NORMAL. ALL QC WITHIN RANGE. PRETREATMENT OPENED (B)(6), 2014. RUN WAS NOT VERIFIED AND NO RESULTS WERE SENT OUT. (B)(6), 2014 VITAMIN D WAS RECALIBRATED AND THE SAME PRETREATMENT WAS USED. SIX SPECIMENS HAD VITAMIN D RESULTS THAT WERE <4.0 NG/ML AND THE RESULTS WERE SENT. (B)(6), 2014 TOSOH BIOSCIENCE, INC. NOTIFIED OF ERRONEOUS VITAMIN D RESULTS THAT HAD BEEN REPORTED BY THE CUSTOMER. (B)(6), 2014 SIX SPECIMENS REPORTED AS <4.0 NG/ML ON (B)(6), 2014 WERE REPEATED, RESULTS WERE NORMAL, AND CORRECTED REPORTS WERE ISSUED. ROOT CAUSE: PRETREATMENT USED BEYOND STATED ROOM TEMPERATURE STABILITY TIME FRAME.