N
Patient 1
THIS EVENT OCCURRED IN (B)(6). (B)(4).
MAUDE MDR 7013360
- MDR report key
- 7013360
- Report number
- 1823260-2017-02563
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-10-20
- Date received
- 2017-11-09
- Adverse event
- 3
- 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ELECSYS T4 ASSAY | RADIOIMMUNOASSAY, TOTAL THYROXINE | ROCHE DIAGNOSTICS | CDX | NA | 12017709122 | 248077 | 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 THE ELECSYS T4 ASSAY (T4) ON A COBAS E 411 IMMUNOASSAY ANALYZER (E411). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED WITH A T4 VALUE OF 18 UG/ML WHEN TESTED ON THE CUSTOMER'S E411 ANALYZER. THE SAMPLE WAS TESTED ON A VIDAS ANALYZER AND THE T4 RESULT WAS 9 UG/ML. THE SAMPLE WAS ALSO TESTED ON A SECOND E411 ANALYZER IN A DIFFERENT LABORATORY, RESULTING WITH A T4 VALUE OF 20 UG/ML. A FRESH SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED. THE VALUES FROM THIS SAMPLE WERE THE SAME AS PREVIOUS VALUES. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBERS OF THE E411 ANALYZERS USED AT THE CUSTOMER SITE AND OTHER LABORATORY WERE ASKED FOR, BUT NOT PROVIDED. THE CUSTOMER DOES NOT USE QUALITY CONTROL MATERIAL. DURING TROUBLESHOOTING, QUALITY CONTROL MATERIAL WAS TESTED ON THE CUSTOMER'S E411 ANALYZER AND RECOVERED WITHIN LIMITS. CALIBRATION SIGNALS WERE WITHIN RANGE ON THE CUSTOMER'S E411 ANALYZER. NO ISSUES WERE FOUND WITH THE CUSTOMER'S E411 ANALYZER. CALIBRATION AND QUALITY CONTROL RECOVERIES AT THE OTHER LABORATORY WERE WITHIN LIMITS.