FDA Adverse Event
Other
Summary report: N
CLINITEK STATUS+ ANALYZER
MDR report key: 3221209
·
Received July 3, 2013
Report
- Report Number
- 1217157-2013-00118
- Event Type
- Other
- Date Received
- July 3, 2013
- Date of Event
- May 29, 2013
- Report Date
- June 6, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Product Code
- JIL
- PMA / PMN Number
- K091216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE DISCORDANT HCG RESULTS IS UNK. AS STATED IN THE IFU, "BORDERLINE: RESULT IS INDETERMINATE, REPEAT IN 48-72 HOURS. 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 REPORTS SEVERAL FALSE POSITIVE HUMAN CHRONIC GONADOTROPIN (HCG) RESULTS ON INSTRUMENT. BLOOD RESULTS SHOWED NEGATIVE HCG RESULTS. PT SURGERY WAS DELAYED DUE TO THE POSITIVE RESULT. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303748 | CLINITEK STATUS+ ANALYZER | CLINITEK STATUS+ ANALYZER | JIL | SIEMENS HEALTHCARE DIAGNOSTICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |