FDA Adverse Event
Malfunction
Summary report: N
URISYS 1100
MDR report key: 3854121
·
Received June 6, 2014
Report
- Report Number
- 1823260-2014-04136
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 7, 2014
- Report Date
- July 17, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JIO
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CORRECTED INFORMATION: THE RESULT OF +2 FOR ERYTHROCYTES WAS OBTAINED ON THE URISYS 1100, WHILE A LABORATORY TEST REPORTED A VALUE OF NEGATIVE. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
REPORTER STATED THAT A NEGATIVE RESULT FOR ERYTHROCYTES WAS OBTAINED ON THE URISYS 1100 WHILE A LABORATORY TEST REPORTED THE RESULT AS +2. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330966 | URISYS 1100 | AUTOMATED URINE ANALYZER | JIO | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |