MalfunctionGIT
DADE ACTIN FS ACTIVATED PTT REAGENT
Received Oct 17, 2005
Report 9610806-2005-00029 · MDR key 702459
Device
Generic name
Activated Partial Thromboplastin Time
Manufacturer
Dade Behring GmbhModel number
NACatalog number
B4218-100
Lot number
527263
Product problems
- High Test Results
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A CUSTOMER OBTAINED ERRONEOUSLY PROLONGED APTT RESULTS WITH 10 PT SAMPLES. ERRONEOUSLY PROLONGED APTT TEST RESULTS HAVE BEEN OBSERVED WITH ABNORMAL CITROL CONTROLS AND PT SAMPLES. UNABLE TO DETERMINE ADVERSE HEALTH CONSEQUENCES TO THE PTS; NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER TO INDICATE THAT PT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN. (NOTE: CUSTOMER UNABLE TO PROVIDE DATE OF EVENT).
Remedial action
- Recall