FDA Adverse Event
Other
Summary report: N
TDXFLX SYSTEM
MDR report key: 187240
·
Received September 11, 1998
Report
- Report Number
- 1628664-1998-00080
- Event Type
- Other
- Date Received
- September 11, 1998
- Date of Event
- August 14, 1998
- Report Date
- September 10, 1998
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- LCQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON OR AROUND 8/14/98, AN ERROR CODE "SAMPLE LEVEL HI" WAS PRINTED ON THE DATA TAPE WHEN AN AMNIOTIC FLUID SAMPLE WAS INITIALLY TESTED FOR TDXFLX FLM II. THE OPERATOR REPORTED THE RESULT AS "HI." THE INITIAL TESTING WAS PERFORMED ON A FRESH SAMPLE. THE SAMPLE WAS RETESTED GIVING A RESULT OF 17.7/17.7 MG/G. THE RETEST WAS PERFORMED ON A FROZEN SAMPLE. THE INFANT WAS IN A BREECH POSITION. WHILE THE PHYSICIAN WAS ATTEMPTING TO CHANGE THE INFANT'S POSITION, THE MOTHER WENT INTO LABOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TDXFLX SYSTEM | AUTOMATED FPIA ANALYZER | LCQ | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other | TDXFLX FLM II REAGENT, LIST NUMBER 7A76. |