LDLC3 LDL-CHOLESTEROL GEN.3
Received Aug 5, 2019 · Event occurred Jul 15, 2019
Report 1823260-2019-02835 · MDR key 8860773
Device
Generic name
Low Density Lipoprotein Test System
Manufacturer
Roche DiagnosticsModel number
LDL-C G3Catalog number
07005768190
Lot number
ASKU
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE INVESTIGATION IS CURRENTLY ONGOING. THE EVENT OCCURRED IN: (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED THAT FOR 1 PATIENT AN INTERFERANT IS AFFECTING THE PATIENT'S CHOL2 CHOLESTEROL GEN.2, HDLC4 HDL-CHOLESTEROL PLUS 4TH GENERATION, AND LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION RESULTS FROM A COBAS 8000 C702 MODULE. THIS MEDWATCH WILL COVER LDL_C. FOR INFORMATION ON HDLC4 REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) AND FOR CHOL2 REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE SPECIFIC DATA HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. THE CUSTOMER STATED THAT THE CHOL2 RESULTS WERE TOO HIGH AND THE HDLC4 AND LDL_C RESULTS WERE TOO LOW. THE RESULTS IN QUESTION HAVE BEEN REPORTED TO THE CLINICIANS. THE COBAS 8000 C702 MODULE SERIAL NUMBER IS (B)(4).