FDA Adverse Event
Other
Summary report: N
CLINITEK STATUS
MDR report key: 3239640
·
Received July 16, 2013
Report
- Report Number
- 1217157-2013-00130
- Event Type
- Other
- Date Received
- July 16, 2013
- Date of Event
- June 26, 2013
- Report Date
- July 5, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Product Code
- DHA
- PMA / PMN Number
- K031947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE FALSE POSITIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT IS UNK. AS STATED IN THE IFU, "AS IS TRUE WITH ANY DIAGNOSTIC TEST, CLINICAL DIAGNOSIS SHOULD NOT BE BASED SOLELY ON A SINGLE TEST RESULT. CLINICAL DIAGNOSIS SHOULD INCORPORATE ALL CLINICAL AND LABORATORY DATA."
Description of Event or Problem · 1
CUSTOMER REPORTED A POSITIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT ON THE INSTRUMENT. THE CUSTOMER REPORTED THAT A SERUM SAMPLE WAS TESTED AND THE HCG RESULT WAS NEGATIVE. THE CUSTOMER REPORTED THAT THE PTS SURGERY WAS CANCELLED DUE TO THE POSITIVE HCG RESULT. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330404 | CLINITEK STATUS | CT STATUS | DHA | SIEMENS HEALTHCARE DIAGNOSTICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |