FDA Adverse Event
Malfunction
Summary report: N
NBCS (NATIONAL BIOMEDICAL COMPUTER SYSTEM)
MDR report key: 243728
·
Received October 7, 1999
Report
- Report Number
- 1124939-1999-00003
- Event Type
- Malfunction
- Date Received
- October 7, 1999
- Date of Event
- September 8, 1999
- Report Date
- October 7, 1999
- Manufacturer
- AMERICAN RED CROSS
- Product Code
- MMH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
A SOFTWARE DEFICIENCY IN THE NATIONAL BIOMEDICAL COMPUTER (NBCS) ALLOWING THE USER TO CREATE TWO DONOR RECORDS WITH THE SAME SOCIAL SECURITY NUMBER (SSN) IN "DMIS" WAS IDENTIFIED DURING A ROUTINE QUERY OF DUPLICATE DONORS BY SSN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NBCS (NATIONAL BIOMEDICAL COMPUTER SYSTEM) | SOFTWARE, BLOOD-BANK (STAND ALONE PRODUCTS) | MMH | AMERICAN RED CROSS | NA | VERSIONS 1.1 TO 1.4.1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |