N
Patient 1
(B)(6).
MAUDE MDR 8178956
- MDR report key
- 8178956
- Report number
- 1823260-2018-05004
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-12-06
- Date received
- 2018-12-19
- 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 CK-MB IMMUNOASSAY | COLORIMETRIC METHOD, CPK OR ISOENZYMES | ROCHE DIAGNOSTICS | JHY | NA | ASKU | ASKU | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-19 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER CONSISTENTLY RECEIVED QUESTIONABLE HIGH TROPONIN T HS, CREATINE KINASE (CK), AND ELECSYS CK-MB IMMUNOASSAY RESULTS FOR ONE PATIENT FROM THE COBAS 8000 COBAS E 602 MODULE SERIAL NUMBER (B)(4). THIS MEDWATCH IS FOR CK-MB. REFER TO THE MEDWATCHS WITH PATIENT IDENTIFIERS (B)(6) AND (B)(6) FOR THE OTHER ASSAYS. THE DOCTOR BELIEVED THE RESULT WERE AN "IMPLAUSIBLE CONSTELLATION OF CARDIAC MARKERS IN CASE OF A SHOWING NO CARDIAC SYMPTOMS". THERE WAS NO EVIDENCE OF AN ACUTE MYOCARDIAL INFARCT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER SUSPECTED A NON-CARDIAC ISOFORM OF TROPONIN T WAS PRESENT.