FDA Adverse Event
Other
Summary report: N
HEMOCHRON SIGNATURE INSTRUMENT/ACT-LR ASSAY
MDR report key: 979475
·
Received January 11, 2008
Report
- Report Number
- 2248721-2008-00003
- Event Type
- Other
- Date Received
- January 11, 2008
- Report Date
- January 11, 2008
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JBP
- PMA / PMN Number
- K960749
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER CONCLUSION - MANUFACTURER AWAITING PRODUCT RETURN. SEE SCANNED PAGES.
Description of Event or Problem · 1
DEVICE 3 OF 3 - MULTIPLE DEVICE REPORT. CUSTOMER REPORTED 6 OCCURENCES OF 'CRANIAL BLEED' OVER A YEAR PERIOD AND INACCURACY OF HEMOCHRON SIGNATURE ACT-LR RESULTS. CUSTOMER NOT ABLE TO PROVIDE FURTHER INFO REGARDING PATIENT OUTCOMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON SIGNATURE INSTRUMENT/ACT-LR ASSAY | HEMOCHRON SIGNATURE ACT-LR | JBP | INTERNATIONAL TECHNIDYNE CORP. | HE-SIG | ASSAY/UNAVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |