FDA Adverse Event
Malfunction
Summary report: N
A LOCUS HIGH RES SSP UNITRAY KIT
MDR report key: 3695232
·
Received January 6, 2014
Report
- Report Number
- 2244574-2014-00002
- Event Type
- Malfunction
- Date Received
- January 6, 2014
- Report Date
- December 5, 2013
- Manufacturer
- LIFE TECHNOLOGIES CORP
- Product Code
- MZI
- PMA / PMN Number
- BK020068
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF A LOCUS HIGH RES SSP UNITRAY KIT, CATALOG #4729010, LOT #012 1306793 IS ON-GOING.
Description of Event or Problem · 1
CUSTOMER IS SEEING RANDOM AND SPORADIC AMPLIFICATION FROM HUMAN TUMOR CELL LINE SAMPLES WITH THE A HIGH RES SSP UNITRAY KIT #(B)(4), LOT 012 1306793 LEADING TO FALSE NEGATIVE RESULTS. CONTROL BANDS ARE PRESENT AND THE CUSTOMER HAS REPRODUCED THE FALSE NEGATIVE RESULTS IN THEIR LAB UPON RETESTING. GEL IMAGES WERE NOT RECEIVED BY TECH SUPPORT FROM THE CUSTOMER BUT HAVE BEEN REQUESTED. THIS RESULTS IN A NO TYPE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6447 | A LOCUS HIGH RES SSP UNITRAY KIT | MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNO | MZI | LIFE TECHNOLOGIES CORP | 012 1306793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |