FDA Adverse Event
Malfunction
Summary report: N
HAMILTON ML AT+
MDR report key: 1647144
·
Received March 31, 2010
Report
- Report Number
- 2250051-2010-00074
- Event Type
- Malfunction
- Date Received
- March 31, 2010
- Date of Event
- March 2, 2010
- Report Date
- March 31, 2010
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JQW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND RE-CALIBRATED THE INSTRUMENT AND REPLACED THE RIBBON CABLE TO PIPETTE HEAD.
Description of Event or Problem · 1
THE HAMILTON ML AT+ INSTRUMENT DID NOT PIPETTE THE CORRECT AMOUNT OF NEGATIVE CONTROL AND DID NOT GENERATE AN ERROR MESSAGE.NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAMILTON ML AT+ | SAMPLE PIPETTER | JQW | HAMILTON BONADUZ AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |