FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON JR SIGNATURE SYSTEM
MDR report key: 2517871
·
Received February 20, 2012
Report
- Report Number
- 2248721-2012-00009
- Event Type
- Malfunction
- Date Received
- February 20, 2012
- Date of Event
- May 27, 2011
- Report Date
- January 27, 2012
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K940401
- Removal / Correction Number
- Z-2953-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (CUVETTE LOT# M0JPT097). METHOD: ACTUAL DEVICE NOT EVALUATED. RESULT: MANUFACTURE NOTIFIED FDA ON OR ABOUT (B)(6) 2011 OF HEMOCHRON JR PT J201 VOLUNTARY RECALL. CONCLUSION: CUVETTE LOTS RECALLED (Z-2953-2011) DUE TO HIGHER THAN SPECIFIED BIAS. CORRECTIVE ACTION (B)(4) IMPLEMENTED.
Description of Event or Problem · 1
THIS IS A MFR'S F/U REPORT TO THE USER FACILITY REPORT REFERENCED ABOVE, RECEIVED BY ITC ON (B)(6) 2012. FOLLOWING NOTIFICATION OF J201 RECALL, CUSTOMER NOTIFIED FDA TO REPORT THAT PT HAVE BEEN ADVERSELY AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON JR SIGNATURE SYSTEM | JPA | INTERNATIONAL TECHNIDYNE CORP. | M0JPT097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other |