N
Patient 1
THIS EVENT OCCURRED IN (B)(6).
MAUDE MDR 6574756
- MDR report key
- 6574756
- Report number
- 1823260-2017-01025
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-01-01
- Date received
- 2017-05-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NA MICHAEL LESLIE
- Address
- 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
- Phone
- 317-317-3175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HDLC HDL-CHOLESTEROL PLUS 3RD GENERATION | LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL | ROCHE DIAGNOSTICS | LBS | NA | ASKU | ASKU | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-18 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION (LDL_C), TOTAL CHOLESTEROL, HDL, AND TRIG ON A COBAS 8000 C 702 MODULE. BASED ON THE INFORMATION PROVIDED, THE HDL AND LDL_C RESULTS WERE ERRONEOUS AND REPORTED OUTSIDE OF THE LABORATORY. THE DATE OF EVENT WAS REQUESTED BUT HAS NOT BEEN PROVIDED. THIS MEDWATCH WILL COVER HDL. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDL_C ERRONEOUS RESULTS. THE INITIAL HDL RESULT FROM THE C702 MODULE WAS 10 (UNIT OF MEASURE NOT PROVIDED). THE REPEAT HDL RESULT USING SEKISUI REAGENT WAS 45 (UNIT OF MEASURE NOT PROVIDED). THE INITIAL LDL_C RESULT FROM THE C702 MODULE WAS 54 (UNIT OF MEASURE NOT PROVIDED). THE REPEAT LDL RESULT USING SEKISUI REAGENT WAS 713 (UNIT OF MEASURE NOT PROVIDED). BOTH SETS OF RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WITH A NOTE INDICATING THAT THE SEKISUI RESULTS WERE PERFORMED USING A DIFFERENT ASSAY AND THAT THERE WAS SUSPECTED LP(X) INTERFERENCE. NO ADVERSE EVENT OCCURRED. THE PATIENT WAS NOT AFFECTED DUE TO THE ROCHE RESULTS. THE PATIENT SAMPLE WAS THEN TESTED BY ELECTROPHORESIS WHERE THE ALPHA ?FRACTION WAS 0.9, THE FREE BETA-FRACTION WAS 13.3 AND THE BETA-FRACTION WAS 85.8. BASED ON THE REFERENCE RANGES, THE BETA-FRACTION RESULT OF 85.8 WAS HIGH AND HYPERLIPOPROTEINEMIA WAS SUSPECTED. THE C702 MODULE SERIAL NUMBER WAS NOT PROVIDED.
N
Patient 1
THE DATE OF EVENT IS AN APPROXIMATE DATE; THE CUSTOMER STATED THE EVENT OCCURRED IN (B)(6) 2016. THE UNIT OF MEASURE FOR TOTAL CHOLESTEROL, TRIG, HDL, LDL_C WAS MG/DL.
N
Patient 1
N
Patient 1
A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL RELATED TEST RESULTS WERE REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. THE PATIENT HAS HEPATITIS, VANISHING BILE DUCT SYNDROME AND OSTEOPOROSIS IN BOTH KNEES. IN PATIENTS WITH THESE CONDITIONS, THE PRESENCE OF LP(X) AND/OR LP(Y) LIPOPROTEINS CAN BE ASSUMED. THESE PROTEINS CAN ONLY BE OBSERVED USING A PARTICULAR TYPE OF LIPOPROTEIN ELECTROPHORESIS. THESE PARTICLES ARE NOT DETECTED OR BARELY DETECTED IN ROCHE'S LDLC3 ASSAY. WITH CHANGED LIVER PATTERNS, IT IS POSSIBLE THAT DIFFERENT DIRECT TEST METHODS GIVE VERY DIFFERENT RESULTS DEPENDING ON THE SENSITIVITY TO ABNORMAL LIPOPROTEINS.