FDA Adverse Event
Malfunction
Summary report: N
NBCS (NATIONAL BIOMEDICAL COMPUTER SYSTEM)
MDR report key: 271540
·
Received March 29, 2000
Report
- Report Number
- 1124939-2000-00001
- Event Type
- Malfunction
- Date Received
- March 29, 2000
- Date of Event
- November 5, 1999
- Report Date
- March 28, 2000
- Manufacturer
- AMERICAN NATIONAL 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
ON NOVEMBER 12, 1999, THE SOUTHWEST REGION REPORTED (CLARIFY CASE NO. 155116) THAT THE NBCS SYSTEM HAD AUTOMATICALLY REMOVED A "2T" ASSERTION FROM A DONOR RECORD BEFORE THE APPROPRIATE END DATE OF THE ASSERTION (SEE MDR #1124939-1999-00001 AND THE FOLLOW-UP TO THAT REPORT). A "2T" ASSERTION IS AUTOMATICALLY PLACED ON A DONOR RECORD FOR 365 DAYS FROM THAT DATE OF A REACTIVE SYPHILIS SCREENING TEST RESULT WHEN THE CONFIRMATORY FINAL INTERPRETATION IS EQUIVOCAL. THIS ASSERTION IS DESIGNED TO PREVENT DISTRIBUTION OF A BLOOD PRODUCT COLLECTED FROM THE DONOR.
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 NATIONAL RED CROSS | NA | VERSION 1.4.1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |