FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 3181492
·
Received June 21, 2013
Report
- Report Number
- 2250051-2013-00169
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 28, 2013
- Report Date
- June 21, 2013
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- MMH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE. THE FE COULD NOT RECREATE THE PROBLEM BY PERFORMING SPLLD CHECKS. THE FE CHECKED HOLDING FORCE OF PLUNGER CLAMPS # 1, #2, #3 AND #4. ALL CLAMPS WERE WITHIN SPECIFICATION. THE FE TESTED THE SUMMIT LLD WITH SPLLD AND (B)(4) SOFTWARE CHECKS. THE INSTRUMENT WAS OPERATING AS EXPECTED. NO REPAIRS NEEDED.
Description of Event or Problem · 1
THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT DID NOT PIPETTE THE CORRECT AMOUNT OF SAMPLE AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282153 | ORTHO SUMMIT SAMPLE HANDLING SYSTEM | SAMPLE PIPETTOR | MMH | HAMILTON BONADUZ AG | 936400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |