N
Patient 1
THIS EVENT OCCURRED IN (B)(6). (B)(4).
MAUDE MDR 7014365
- MDR report key
- 7014365
- Report number
- 1823260-2017-02567
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-10-23
- Date received
- 2017-11-09
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- 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 C (501) MODULE | CLINICAL CHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | CEO | C501 | 04745914001 | NA | R | Y | |||
| 1 | COBAS 6000 C (501) MODULE | CLINICAL CHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | JJE | C501 | 04745914001 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-11-09 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR PHOS2 PHOSPHATE (INORGANIC) VER.2 - PHOS ON A COBAS 6000 C (501) MODULE - C501. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 6.16 MG/DL. THE SAMPLE WAS REPEATED ON (B)(6) 2017, RESULTING AS 3.34 MG/DL. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PHOS REAGENT LOT NUMBER WAS 196352, WITH AN EXPIRATION DATE OF 31-JAN-2018. CALIBRATION AND QUALITY CONTROL RECOVERY WERE OK.