FDA Adverse Event
Other
Summary report: N
TESTPACK PLUS HCG
MDR report key: 512680
·
Received February 18, 2004
Report
- Report Number
- 1451914-2004-00002
- Event Type
- Other
- Date Received
- February 18, 2004
- Date of Event
- January 27, 2004
- Report Date
- February 17, 2004
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- JHJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A PT PRESENTED TO THE EMERGENCY CENTER WITH SYMPTOMS OF A COLD IN 2003 AND IT WAS DETERMINED THAT CERTAIN MEDICATIONS BE PRESCRIBED FOR THEM. A URINE SAMPLE WAS COLLECTED AT THAT TIME AND TESTED WITH THE ABBOTT TESTPACK +PLUS HCG URINE ASSAY. THE ASSAY GENERATED A NEGATIVE RESULT AND THE MEDICATION WAS ADMINISTERED. THE PT SUBSEQUENTLY MISCARRIED IN 2004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TESTPACK PLUS HCG | RAPID PREGNANCY TEST | JHJ | ABBOTT LABORATORIES | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |