FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
MDR report key: 3181909
·
Received June 21, 2013
Report
- Report Number
- 2250051-2013-00170
- 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND FOUND THE PLUNGER IN POSITION # 3 AND 10 WERE FAULTY. THE PLUNGER CLAMPS WERE REPLACED. THE FE TESTED THE SUMMIT LLD WITH SPLLD AND (B)(4) SOFTWARE. ALL TEST PASSED WITHOUT ERROR. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION
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 |
|---|---|---|---|---|---|---|---|
| 282084 | ORTHO SUMMIT SAMPLE HANDLING SYSTEM | SAMPLE PIPETTOR | MMH | HAMILTON BONADUZ AG | 934600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |