FDA Adverse Event
Other
Summary report: N
SCREENING CELLS TRIO
MDR report key: 384877
·
Received March 25, 2002
Report
- Report Number
- 1623424-2002-00001
- Event Type
- Other
- Date Received
- March 25, 2002
- Date of Event
- February 21, 2002
- Report Date
- March 25, 2002
- Manufacturer
- GAMMA BIOLOGICALS, INC.
- Product Code
- KSZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PT EXPERIENCED A DELAYED TRANSFUSION REACTION. PT EXHIBITED A SLIGHT ELEVATION IN TEMPERATURE. THE PT WAS STABLE AND THERE WERE NO COMPLICATIONS AT THE TIME OF THE REPORTED REACTION. THE PT'S PRE-TRANSFUSION SAMPLE WAS INITIALLY FOUND TO BE NEGATIVE. AFTER THE DELAYED TRANSFUSION REACTION OCCURRED, THE PRE-TRANSFUSION SAMPLE WAS RETESTED AND FOUND TO BE POSITIVE FOR ANTI-JKA. IN-HOUSE TESTING OF RETENTIONS SHOWED THE PRODUCT TO BE PERFORMING ACCORDING TO SPECS. REPEAT TESTING OF THE PRE-TRANSFUSION SAMPLE, BY THE USER FACILITY, SHOWED THAT THE PRODUCT PERFORMED ACCORDING TO SPECS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREENING CELLS TRIO | IN-VITRO DIAGNOSTIC | KSZ | GAMMA BIOLOGICALS, INC. | NA | 0115793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |