FDA Adverse Event
Malfunction
Summary report: N
HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST
MDR report key: 3050308
·
Received March 7, 2013
Report
- Report Number
- 2027969-2013-00199
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 4, 2013
- Report Date
- March 7, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- JHI
- PMA / PMN Number
- K993317
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGED RECEIVING 2 FALSE NEGATIVE RESULTS. CUSTOMER WAS ONLY ABLE TO PROVIDE DATA ON ONE PT; PT VISIT ON (B)(6) 2013 ((B)(6) 2012) NEGATIVE PREGNANCY TEST IN OFFICE AFTER 3 MINS TIME, HCG QUANT TOTAL AT LAB OF 1740 DRAWN AT 11:20 AM. PT SPECIMEN WAS REPORTED AS FRESH. INTERNAL AND EXTERNAL CONTROLS WERE REPORTED AS FINE. NO PT SAMPLES WERE AVAILABLE FOR INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98461 | HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST | HCG PREGNANCY | JHI | ALERE SAN DIEGO, INC. | FHC-102-KHS25 | HCG2030271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |