FDA Adverse Event
Malfunction
Summary report: N
BALLISTA INSTRUMENTS
MDR report key: 1622418
·
Received March 4, 2010
Report
- Report Number
- 2242816-2010-00014
- Event Type
- Malfunction
- Date Received
- March 4, 2010
- Date of Event
- February 9, 2010
- Report Date
- February 10, 2010
- Manufacturer
- EBI, LLC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DHR WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED.
Description of Event or Problem · 1
IT HAS BEEN REPORTED, DURING SURGERY, IT WAS IDENTIFIED THAT ONE OF THE TEETH OF THE INSERTER HAD BROKEN OFF. THE BROKEN PIECE WAS NEITHER RECOVERED OR VISABLE ON EITHER THE LATERAL OR AP RADIOGRAPHS. PATIENT OUTCOME: NO ADVERSE AFFECT REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH BASOPHIL DIFFERENTIAL RESULTS GENERATED BY THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER FOR ONE PATIENT. THE SPECIMEN WAS RERUN TWICE ON AN ALTERNATE UNIT AND LOWER RESULTS WERE OBTAINED. MANUAL DIFFERENTIAL WAS NOT PERFORMED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BALLISTA INSTRUMENTS | ROD INSERTER | LXH | EBI, LLC | P078856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |