FDA Adverse Event
Malfunction
Summary report: N
DATACARE POC
MDR report key: 388136
·
Received April 9, 2002
Report
- Report Number
- 1823260-2002-00105
- Event Type
- Malfunction
- Date Received
- April 9, 2002
- Date of Event
- March 21, 2002
- Report Date
- April 8, 2002
- Manufacturer
- RDC - ROSWELL
- Product Code
- JQP
- Removal / Correction Number
- 1823260-3/27/02-004-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSP DATA MGMT CONNECTIVITY SOFTWARE FOR DIAGNOSTIC DEVICES - IF THE OPERATOR DOES NOT VERIFY CORRECT RESULTS ARE SELECTED, A MISMATCH OF RESULTS TO AN INCORRECT PT ID COULD OCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DATACARE POC | HOSPITAL DATA MGMT CONNECTIVITY SOFTW | JQP | RDC - ROSWELL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |