FDA Adverse Event
Malfunction
Summary report: N
THE SUPPLY EXPERTS HCG URINE - CASSETTE
MDR report key: 3853848
·
Received April 18, 2014
Report
- Report Number
- 2027969-2014-00355
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- March 20, 2014
- Report Date
- March 27, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- JHI
- PMA / PMN Number
- K993317
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES POTENTIAL FALSE NEGATIVE HCG RESULTS USING THE SUPPLY EXPERTS HCG URINE - CASSETTE. PATIENT SELF TESTED AT HOME USING AN UNKNOWN OVER THE COUNTER (OTC) KIT AND RECEIVED A POSITIVE RESULT. RESULT IN OFFICE USING THE SUPPLY EXPERTS HCG URINE - CASSETTE WAS NEGATIVE. QUANTITATIVE BLOOD RESULT WAS NOT AVAILABLE. THE TESTING TIME WAS AFTER 10 AM. THE PHYSICIAN DIAGNOSED PATIENT AS PREGNANT BY CLINICAL AND ULTRASOUND. KIT STORAGE: ROOM TEMP. EXTERNAL CONTROL: NORMAL. PROCEDURE: VERIFIED BY TSS. OTHER PATIENT RESULTS: NORMAL AS EXPECTED. THERE WAS NO REPORTED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238705 | THE SUPPLY EXPERTS HCG URINE - CASSETTE | HCG PREGNANCY TEST | JHI | ALERE SAN DIEGO, INC. | FHC-102-OBW01 | HCG3070036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |