FDA Adverse Event
Malfunction
Summary report: N
SECORE DRB1 LOCUS SEQUENCING KIT
MDR report key: 3704693
·
Received January 17, 2014
Report
- Report Number
- 2244574-2014-00048
- Event Type
- Malfunction
- Date Received
- January 17, 2014
- Report Date
- December 16, 2013
- Manufacturer
- LIFE TECHNOLOGIES CORPORATION
- Product Code
- MZI
- PMA / PMN Number
- BK110038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SECORE DRB1 LOCUS SEQUENCING KIT, CATALOG #5330025, LOT #1216962 IS ON-GOING.
Description of Event or Problem · 1
CUSTOMER IS REPORTING HIGH BACKGROUND AND NORMAL SIGNAL STRENGTH IN MULTIPLE LOTS OF SECORE KITS A, B, C AND DRB1. THIS WOULD RESULT IN A NO TYPE. CUSTOMER COMPLAINT WAS REPORTED BY MFR REP. SECORE DRB1 LOCUS SEQUENCING KIT, CATALOG #5330025, LOT #1216962 HAS BEEN IDENTIFIED IN THE COMPLAINT AS HAVING THIS PROBLEM. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46228 | SECORE DRB1 LOCUS SEQUENCING KIT | MZI TEST, QUALITATIVE FOR HLA, NON-D | MZI | LIFE TECHNOLOGIES CORPORATION | 1216962 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |