FDA Adverse Event
Malfunction
Summary report: N
LITHIUM TEST KIT
MDR report key: 2318281
·
Received November 1, 2011
Report
- Report Number
- 2050012-2011-07057
- Event Type
- Malfunction
- Date Received
- November 1, 2011
- Date of Event
- October 5, 2011
- Report Date
- October 5, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- NDW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, THE BECKMAN COULTER SITE IN (B)(6) REPORTED THAT THEY RECEIVED A BOTTLE OF LITHIUM REAGENT THAT HAD LEAKED. THERE WAS NO EXPOSURE OR INJURY TO THE OPERATOR. UPON RECUR, IT IS UNKNOWN IF SERIOUS INJURY COULD OCCUR, SO IT WAS DETERMINED THAT AN MDR SHOULD BE FILED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LITHIUM TEST KIT | ASSAY, PORPHYRIN, SPECTROPHOTOMETRY, LITHIUM | NDW | BECKMAN COULTER, INC. | M010761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |