FDA Adverse Event
Malfunction
Summary report: N
RAPIDPOINT 500
MDR report key: 3912367
·
Received July 3, 2014
Report
- Report Number
- 1217157-2014-00097
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- June 7, 2014
- Report Date
- June 9, 2014
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- KQO
- PMA / PMN Number
- K113216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER SHOULD NOT HAVE RUN PATIENT SAMPLES WHEN AUTOMATIC QUALITY CONTROL (AQC) WAS TURNED OFF ON THE INSTRUMENT. CUSTOMER CONFIRMED THAT NO PATIENT RESULTS WERE QUESTIONED DURING THIS TIME FRAME AND NO TREATMENT WAS AFFECTED. SIEMENS HAS ISSUED SIEMENS KNOWLEDGE BASE (SKB) IN ORDER TO INFORM CUSTOMERS TO TURN AUTOMATIC QUALITY CONTROL (AQC) BACK ON BEFORE RUNNING PATIENT SAMPLES ON THE INSTRUMENT. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT AUTOMATIC QUALITY CONTROL(AQC) WAS DESELECTED IN THE SETUP ON THE INSTRUMENT DURING (B)(6) 2014. CUSTOMER ALSO REPORTED THAT PATIENT SAMPLES WERE RUN DURING THIS TIMEFRAME. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390804 | RAPIDPOINT 500 | RP 500 | KQO | SIEMENS HEALTHCARE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |