FDA Adverse Event
Injury
Summary report: N
TOSOH AIA-900
MDR report key: 3324270
·
Received August 26, 2013
Report
- Report Number
- 3005529799-2013-00012
- Event Type
- Injury
- Date Received
- August 26, 2013
- Date of Event
- August 2, 2013
- Report Date
- August 27, 2013
- Manufacturer
- TOSOH BIOSCIENCE, INC.
- Product Code
- CHP
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, TOSOH BIOSCIENCE WAS NOTIFIED BY AN ACCOUNT THAT AN ESTRADIOL RESULT WAS QUESTIONED BY A PHYSICIAN. THE RESULT HAD BEEN REPORTED AFTER THE ANALYZER GAVE A CLOG DETECT ERROR AND THEN RAN OUT OF SUBSTRATE. WHEN THE SUBSTRATE WAS REPLACED THE PROCEDURE FOR SUBSTRATE REPLACEMENT WAS NOT COMPLETED. WHEN THE RESULT WAS QUESTIONED THE ENTIRE RUN OF N= 20 WAS REPEATED WITH 3 RESULTS BEING CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416182 | TOSOH AIA-900 | AIA-900 | CHP | TOSOH BIOSCIENCE, INC. | AIA-900 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |