N
Patient 1
(B)(4). THIS EVENT OCCURRED IN (B)(6).
MAUDE MDR 6800837
- MDR report key
- 6800837
- Report number
- 1823260-2017-01728
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-13
- Date received
- 2017-08-17
- 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 8000 E 602 MODULE | IMMUNOCHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | JKR | E602 | 05990378001 | NA | R | Y | |||
| 1 | COBAS 8000 E 602 MODULE | IMMUNOCHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | JJE | E602 | 05990378001 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-17 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER OBTAINED A QUESTIONABLE HIGH RESULT FOR ONE PATIENT SAMPLE USING THE ELECSYS CALCITONIN IMMUNOASSAY (CALC) ON THE COBAS 8000 E 602 MODULE. ALL RESULTS ARE IN UNITS OF PG/ML. NO DATA FLAGS OR ALARMS OCCURRED UNLESS OTHERWISE SPECIFIED. THE INITIAL RESULT WAS 2000 WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED AND REPEATED WITH A RESULT OF 53263. THIS RESULT WAS RELEASED OUTSIDE THE LABORATORY TO THE CLINICIAN. THE CLINICIAN REQUESTED THAT THE SAMPLE BE CHECKED AND REPEATED, SINCE THIS RESULT WAS MUCH LARGER THAN THE PATIENT'S PREVIOUS RESULTS. THE CUSTOMER MANUALLY DILUTED THE SAMPLE AND OBTAINED THE FOLLOWING RESULTS: 34625 (25X DILUTION), 31740 (50X DILUTION), AND 25900 (100X DILUTION). THESE RESULTS WERE MORE IN LINE WITH THE PATIENT'S RESULTS FROM TWO WEEKS PRIOR TO THE EVENT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CALC REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED; HOWEVER, THE REAGENT PACK WAS EXPIRED AT THE TIME OF THE EVENT. CALIBRATION WAS ACCEPTABLE. THE NUMBER OF MEASURING CELL DETERMINATIONS WAS VERY HIGH. INVESTIGATION ACTIVITIES ARE ONGOING.