FDA Adverse Event
Other
Summary report: N
ORTHO SUMMIT TH SAMPLE HANDLING SYSTEM
MDR report key: 119966
·
Received September 12, 1997
Report
- Report Number
- 2250051-1997-00081
- Event Type
- Other
- Date Received
- September 12, 1997
- Date of Event
- August 22, 1997
- Report Date
- September 9, 1997
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO RECEIVED INDICATES THAT THERE WAS NO INSTRUMENT
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING THE PIPETTING OF AN HTLV-I ASSAY USING SUMMIT SAMPLE HANDLER, THERE WERE BUBBLES IN ROW H OF THE PLATE. THE CUSTOMER WAS ASKED WHEN THE BUBBLES OCCURRED, AND THEY WERE UNABLE TO OFFER ADDITIONAL DETAILS. THEY DID NOT NOTICE THE BUBBLES UNTIL AFTER THE PLATE WAS COMPLETED. NO ERROR MESSAGE WAS GIVEN. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO DIAGNOSTIC SYSTEMS COMPLAINT NUMBER 97-04267-08.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO SUMMIT TH SAMPLE HANDLING SYSTEM | SAMPLE HANDLER | JTC | HAMILTON BONADUZ AG | 135028 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |