N
Patient 1
THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4). THE PATIENT AGE WAS ALSO PROVIDED AS (B)(6). A CLARIFICATION HAS BEEN REQUESTED. THE FULL FACILITY NAME WAS PROVIDED AS (B)(6). PHONE NUMBER WAS PROVIDED AS "(B)(6)".
MAUDE MDR 5735619
- MDR report key
- 5735619
- Report number
- 1823260-2016-00785
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-06-04
- Date received
- 2016-06-20
- 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 8000 E602 MODULE | IMMUNOCHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | JMG | E602 | 05990378001 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-06-20 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR FERRITIN ON THE E602 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 33.29 UG/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY THE CLINICIAN SINCE IT DID NOT FIT WITH PREVIOUS RESULTS FOR THE PATIENT. THE INITIAL RESULT WAS ALSO SAID TO NOT FIT A SUBSEQUENT RESULT. THE SAMPLE WAS REPEATED WITH AN AUTOMATIC DILUTION, RESULTING AS 6177 UG/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FERRITIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED PINCH VALVE TUBINGS AND A VALVE. HE ALSO PERFORMED PREVENTIVE MAINTENANCE ON THE ANALYZER, INCLUDING RUNNING A FISHING LINE THROUGH THE SIPPER FLOW PATH, REAGENT PROBE, AND TUBING. HE PERFORMED A "SYSTEM VOLUME". CONTROLS WERE RUN FOR ALL ASSAYS AND THESE WERE OK. HE FOUND THAT A FUSE WAS BLOWN AND HE REPLACED THIS, BUT IT BLEW AGAIN. HE REPLACED A PRINTED CIRCUIT BOARD WITHIN THE ANALYZER.
N
Patient 1
THE PATIENT'S DATE OF BIRTH OF (B)(6) 1985 HAS BEEN CONFIRMED TO BE CORRECT, SO THE PATIENT WAS (B)(6) AT THE TIME OF THE EVENT.
N
Patient 1
THE RESULT OF 6177 G/L WAS BELIEVED TO BE CORRECT, AS THE PATIENT HAS A HISTORY OF HAVING A HIGH FERRITIN. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE MOST LIKELY ROOT CAUSE WOULD BE RELATED TO PRE-ANALYTIC HANDLING OF THE SAMPLE. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE EVENT WAS NOT REPRODUCIBLE.