FDA Adverse Event
Malfunction
Summary report: N
SURESTEP ONE STEP HCG PREGNANCY TEST
MDR report key: 2070706
·
Received April 14, 2011
Report
- Report Number
- 2027969-2011-00817
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- February 28, 2011
- Report Date
- April 14, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- JHI
- PMA / PMN Number
- K993317
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER REPORTED FALSE NEGATIVE HCG RESULTS. PATIENT 2: URINE TEST AT 1115, BHCG TEST AT 1140, CONFIRMED PREGNANCY, DID NOT USE FIRST MORNING URINE SAMPLE. MISCARRIAGE AT 6/40. PT FIT AND WELL ON DISCHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP ONE STEP HCG PREGNANCY TEST | HCG PREGNANCY TEST | JHI | ALERE SAN DIEGO, INC. | FHC-102 | HCG0050288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |