FDA Adverse Event
Malfunction
Summary report: N
SURE-VUE SERUM/URINE HCG-STAT
MDR report key: 2063057
·
Received April 11, 2011
Report
- Report Number
- 2027969-2011-00761
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 15, 2011
- Report Date
- April 11, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- JHI
- PMA / PMN Number
- K062361
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER REPORTED A FALSE NEGATIVE HCG RESULT WHEN TESTING PT SAMPLE ON SURE-VUE SERUM/URINE HCG STAT TEST VS. LAB METHOD. CALLER STATES REPORT WAS REC'D FROM AN OFF SITE LAB WHO RAN A SCREEN ON A PT WHO CLAIMED TO HAVE SUBJECTED HERSELF TO A HOME PREGNANCY KIT WITH A POSITIVE RESULT. ATTENDING MD DECIDED TO REQUEST HCG USING SURE-VUE SERUM/URINE HCG STAT TEST; IT GAVE A NEGATIVE RESULT. THE SPECIMEN WAS THEN SENT TO THE LAB FOR QUANTIFICATION USING THE SIEMENS WITH THE FOLLOWING DATA - 70,000 MIU/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURE-VUE SERUM/URINE HCG-STAT | HCG PREGNANCY TEST | JHI | ALERE SAN DIEGO, INC. | FHC-A202-OBC513 | HCG0070130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |