FDA Adverse Event
Other
Summary report: N
UF-1000I WITH URINALYSIS
MDR report key: 2974232
·
Received February 12, 2013
Report
- Report Number
- 1217157-2013-00021
- Event Type
- Other
- Date Received
- February 12, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- SYSMEX
- Product Code
- KQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4) RULES FIRED AND SECOND RULE CONVERTED BACTERIA RESULT TO NEGATIVE. THE CAUSE OF THIS EVENT IS NOT KNOWN AT THIS TIME.
Description of Event or Problem · 1
BACTERIA RESULT IS NOT CROSSING TO LIS. A SAMPLE THAT HAD 3120 BACTERIA/UL. UF REPORTED RANK OF 2+ AND LIS RECEIVED A VALUE OF NONE FROM (B)(4). CUSTOMER INDICATED TWO RESULTS CAME OVER FOR THE SAMPLE. THE FIRST WAS CORRECT AND THE SECOND RESULT WAS "NONE SEEN." NO REPORT OF INJURY SEEN WITH THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62228 | UF-1000I WITH URINALYSIS | UF-1000I | KQO | SYSMEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |