N
Patient 1
UNIQUE IDENTIFIER (UDI)# (B)(4). THE EVENT OCCURRED IN: (B)(6).
MAUDE MDR 7454646
- MDR report key
- 7454646
- Report number
- 1823260-2018-01266
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-04-11
- Date received
- 2018-04-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | TRIGL TRIGLYCERIDES | TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL | ROCHE DIAGNOSTICS | CDT | NA | 05171407190 | 25141601 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-04-24 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER COMPLAINED OF A QUESTIONABLE RESULT FOR 1 PATIENT TESTED FOR TRIGL TRIGLYCERIDES (TRIGL) ON A COBAS 8000 C (701) MODULE. THE INITIAL TRIGL RESULT WAS 182 MG/DL. THE SAME SAMPLE WAS RETESTED WITH A 1:20 DILUTION WITH A RESULT OF 10683 MG/DL. THE ERRONEOUS RESULT WAS RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TRIGL REAGENT LOT WAS 25141601 WITH AN EXPIRATION DATE OF 30-JUN-2018. THE INVESTIGATION IS CURRENTLY ONGOING.