ICHEM VELOCITY CONTROL
Received Dec 11, 2013 · Event occurred Aug 31, 2013
Report 2023446-2013-00037 · MDR key 3636149
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CUSTOMER GETTING DISCORDANT RESULTS WITH 20 PATIENTS BETWEEN ICHEM VELOCITY (NEGATIVE) AND IQ200 (POSITIVE). CUSTOMER REPORTED THAT ONE PATIENT SAMPLE WAS NEGATIVE ON CHEMISTRY AND HAD >45 RBC'S. THE OTHER 19 PATIENT SAMPLES WERE ALSO NEGATIVE ON CHEMISTRY AND HAD APPROXIMATELY 5 RBC'S. THE PRESENCE OF RBC'S WAS CONFIRMED WITH MANUAL MICROSCOPE IN ALL PATIENTS.
Additional Manufacturer Narrative
(B)(4). IRIS PRODUCT IFU INSERT STATES THAT THE DIAGNOSTIC OR THERAPEUTIC DECISIONS SHOULD NOT BE BASED ON ANY SINGLE RESULT OR METHOD. NO REPORTS OF CHANGE IN PATIENT MANAGEMENT OR INJURIES WERE REPORTED. THE FOLLOWING MDRS ARE RELATED TO THIS EVENT. 2023446-2013-0024, -00025, -00026, -00027, -00028, -00029, -00030, -00031, -00032, -00033, -0034, -00035, -00036, -00037, -00038, -00039, -00040, -00041, -00042.