FDA Adverse Event
Other
Summary report: N
IMMULITE 2500 CK-MB ASSAY
MDR report key: 1240877
·
Received November 6, 2008
Report
- Report Number
- 2017183-2008-00042
- Event Type
- Other
- Date Received
- November 6, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 8, 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
- NM, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THE CAUSE OF THE DISCORDANT CK-MB RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A NEGATIVE IMMULITE 2500 CK-MB PATIENT SAMPLE RESULT WAS OBTAINED. UPON REPEAT, THE RESULT WAS POSITIVE AND REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED ON 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 | 126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |