FDA Adverse Event
Other
Summary report: N
TESTPACK PLUS HCG-COMBO
MDR report key: 315652
·
Received February 9, 2001
Report
- Report Number
- 1451914-2001-00001
- Event Type
- Other
- Date Received
- February 9, 2001
- Date of Event
- January 4, 2001
- Report Date
- February 6, 2001
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- JHJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A FALSE NEGATIVE TESTPACK PLUS HCG COMBO OBC RESULT WAS REPORTED TO THE EMERGENCY ROOM. THE RESULT WAS QUESTIONED AND THE SAME SERUM SAMPLE WAS RETESTED AND GAVE A STRONG POSITIVE RESULTS. THE QUANTITATIVE BHCG WAS 2,956 MIU/ML.
Description of Event or Problem · 1
A FALSE NEGATIVE RESULT WAS OBTAINED ON A SECOND PT SERUM SAMPLE USING THE TESTPACK PLUS HCG COMBO OBC ASSAY. THE SAMPLE WAS POSITIVE ON A QUANTITATIVE ASSAY (MOTHOD UNKNOWN AND QUANTITATIVE RESULT NOT STATED). THE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INFORMATION REGARDING THE SECOND PT WAS RECEIVED AFTER THE INITIAL FILLING WAS SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4933 | TESTPACK PLUS HCG-COMBO | RAPID PREGNANCY TEST | JHJ | ABBOTT LABORATORIES | NA | 68047M300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |