FDA Adverse Event
Other
Summary report: N
IMMULITE 2500 CK-MB ASSAY
MDR report key: 1449650
·
Received March 10, 2009
Report
- Report Number
- 2017183-2008-00072
- Event Type
- Other
- Date Received
- March 10, 2009
- Date of Event
- June 30, 2008
- Report Date
- July 31, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS LTD.
- Product Code
- JHX
- PMA / PMN Number
- K034055
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
AN ELEVATED IMMULITE 2500 CK-MB PT SAMPLE RESULT WAS OBTAINED. PHYSICIAN QUESTIONED THE RESULTS BECAUSE IT DID NOT MEET THE CLINICAL PICTURE. UPON REPEAT, THE RESULT WAS IN LINE WITH PT CONDITION AND REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CK-MB RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2500 CK-MB ASSAY | CKMB IMMUNOASSAY | JHX | SIEMENS HEALTHCARE DIAGNOSTICS LTD. | NA | 125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |