N
Patient 1
(B)(4). THE EVENT OCCURRED IN (B)(6).
MAUDE MDR 6954179
- MDR report key
- 6954179
- Report number
- 1823260-2017-02345
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-09-29
- Date received
- 2017-10-17
- Adverse event
- 0
- 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | COBAS 6000 CORE UNIT | CLINICAL CHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | MQM | COBAS 6000 CORE | ASKU | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-17 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER COMPLAINED OF A DISCREPANT BILT3 BILIRUBIN TOTAL GEN.3 (BILT3) RESULT ON ONE NEONATE PATIENT. THE INITIAL BILT3 RESULT WAS 508.5 ?MOL/L. THE PATIENT HAD PHOTOTHERAPY ALONG WITH A GLUCOSE INFUSION STARTED BASED ON THIS INITIAL RESULT. THE PHYSICIAN DID NOT BELIEVE THE INITIAL RESULT AND REQUESTED THE SAMPLE TO BE RETESTED ALONG WITH HAVING ANOTHER BLOOD SAMPLE DRAWN. THE REPEAT BILT3 RESULT FROM THE ORIGINAL SAMPLE WAS 290 ?MOL/L. THE REDRAW SAMPLE ALSO HAD A BILT3 RESULT OF