FDA Adverse Event
Malfunction
Summary report: N
ONE STEP + HCG URINE STRIP TEST
MDR report key: 927374
·
Received October 10, 2007
Report
- Report Number
- 3005689981-2007-00017
- Event Type
- Malfunction
- Date Received
- October 10, 2007
- Date of Event
- September 28, 2007
- Report Date
- October 1, 2007
- Manufacturer
- INNOVACON, INC.
- Product Code
- LCX
- PMA / PMN Number
- K993203
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RETAIN SAMPLE TESTING PENDING.
Description of Event or Problem · 1
FALSE NEGATIVE RESULT WAS OBTAINED USING A ONE STEP+ HCG URINE STRIP TEST. THE PREGNANCY WAS CONFIRMED BY BLOOD TEST. HOWEVER, NO NUMBERS WERE OBTAINED AND IT IS NOT CLEAR IF HCH LEVEL WAS ABOVE 25 MIU/ML- THE SENSITIVITY OF THE TEST. IT WAS ALSO NOTED THAT URINE SPECIMEN WAS NOT THE FIRST MORNING SAMPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE STEP + HCG URINE STRIP TEST | ONE STEP PREGNANCY TEST | LCX | INNOVACON, INC. | FHC-101-KHS25 | HCG7060117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |