FDA Adverse Event
Malfunction
Summary report: N
ID-MTS A/B/D MONOCLONAL GROUPING CARD
MDR report key: 468059
·
Received June 20, 2003
Report
- Report Number
- 1056600-2003-00012
- Event Type
- Malfunction
- Date Received
- June 20, 2003
- Report Date
- June 20, 2003
- Manufacturer
- MICRO TYPING SYSTEMS, INC.
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED ABO DISCREPANCY BETWEEN CURRENT TEST RESULTS AND HISTORICAL ABO TYPE. DONOR IS A KNOWN B, BUT WAS FORWARD TYPED AS AN O IN MTS A/B/D MONOCLONAL GROUPING CARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ID-MTS A/B/D MONOCLONAL GROUPING CARD | BLOOD GROUPING REAGENT | KSZ | MICRO TYPING SYSTEMS, INC. | * | 080802053-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |