N
Patient 1
THIS EVENT OCCURRED IN (B)(6). (B)(4).
MAUDE MDR 6184883
- MDR report key
- 6184883
- Report number
- 1823260-2016-01984
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-06
- Date received
- 2016-12-19
- 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 | ALBUMIN TINA-QUANT ALBUMIN | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | ROCHE DIAGNOSTICS | JIR | NA | 03576108190 | 139356 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-19 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT URINE SAMPLE TESTED FOR ALBUMIN TINA-QUANT ALBUMIN (MALB) ON A JCA-BM8040 ANALYZER (MANUFACTURED BY JEOL). THE SAMPLE INITIALLY RESULTED AS 3497.3 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY A PHYSICIAN. THE CUSTOMER ALSO STATED THAT THE RESULT DIFFERED FROM A PREVIOUS SAMPLE TESTED ON (B)(6) 2016. THE VALUE OF THE PREVIOUS SAMPLE COULD NOT BE PROVIDED. THE SAMPLE WAS THEN DILUTED 100 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 3500 MG/DL. THE SAMPLE WAS DILUTED 200 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 1720 MG/DL. THE SAMPLE WAS DILUTED 400 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 1400 MG/DL. THE SAMPLE WAS ALSO DILUTED 800 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 640 MG/DL. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED.
N
Patient 1
PRELIMINARY INVESTIGATIONS PERFORMED WITH THE AFFECTED PATIENT SAMPLE AND THE SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2016 PRIOR TO THE FLUORESCITE TREATMENT SHOWED LINEARITY UNTIL 800 FOLD DILUTION.
N
Patient 1
INVESTIGATIONS HAVE DETERMINED THAT THE FLUORESCINE DOES NOT HAVE ANY IMPACT ON THE MEASURED RESULTS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED.