FDA Adverse Event
Other
Summary report: N
ICON 25 HCG
MDR report key: 524440
·
Received February 13, 2004
Report
- Report Number
- 2916283-2004-00004
- Event Type
- Other
- Date Received
- February 13, 2004
- Date of Event
- January 14, 2004
- Report Date
- February 13, 2004
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JHJ
- Removal / Correction Number
- NOT APPLICABLE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER INDICATED THAT AN EMERGENCY ROOM (ER) PT HAD A URINE SAMPLE TESTED WITH AN ICON 25 HCG TEST KIT AND THE HCG RESULT WAS NEGATIVE (-). A SERUM SAMPLE WAS ALSO COLLECTED FROM THE PT AND WAS TESTED QUANTITATIVELY FOR BHCG. THE QUANTITATIVE BHCG RESULT WAS >200,000 MIU/ML. THE URINE SAMPLE WAS RETESTED USING A DIFFERENT TYPE OF HCG TEST KIT AND THE RESULT WAS POSITIVE (+). THERE HAS BEEN NO CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICON 25 HCG | QUALITATIVE HCG TEST | JHJ | BECKMAN COULTER, INC. | NA | HCG030605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |