D
Patient 1
A CUSTOMER REPORTED OBSERVING FALSELY LOW CKMB RESULTS USING A QC FLUID. FALSE LOW RESULTS MIGHT LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THER WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.
MAUDE MDR 592759
- MDR report key
- 592759
- Report number
- 1319809-2005-00118
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-05-17
- Date received
- 2004-06-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- TOM SMITH
- Address
- 100 INDOGO CREEK DR ROCHESTER NY 14626 US
- Phone
- 585-585-5854
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VITROS CHEMISTRY PRODUCTS CKMB SLIDES | IN VITRO DIAGNOSTIC | ORTHO-CLINICAL DIAGNOSTICS, INC. | JJT | NA | 8058232 | 4912-0130-5667 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-06-08 | 0 |