FDA Adverse Event
Malfunction
Summary report: N
LDX
MDR report key: 2515433
·
Received March 29, 2012
Report
- Report Number
- 2027969-2012-00429
- Event Type
- Malfunction
- Date Received
- March 29, 2012
- Date of Event
- March 2, 2012
- Report Date
- March 29, 2012
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- CHH
- PMA / PMN Number
- K901900
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED THAT THEIR LDX PRINTER IS SMOKING AND GETS EXTREMELY HOT. THE PRINTER BURNED A WHOLE THROUGH A LABEL WHILE PRINTING. CUSTOMER ALSO REPORTED THAT THE PRINTER DOES NOT POWER OFF AND HAS TO BE UNPLUGGED TO TURN OFF. NO REPORT OF DEATH OR SERIOUS INJURY. TECHNICAL SERVICES REPLACED PRINTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LDX | PRINTER, THERMAL, 110V | CHH | ALERE SAN DIEGO, INC. | 11-781 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |