FDA Adverse Event
Malfunction
Summary report: N
RAPIDPOINT 500
MDR report key: 3872621
·
Received June 13, 2014
Report
- Report Number
- 1217157-2014-00085
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- March 16, 2014
- Report Date
- March 27, 2014
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- CHL
- PMA / PMN Number
- K113216
- Removal / Correction Number
- 1217157-05-20-2014-003-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT SOME RAPIDPOINT 500 MEASUREMENT CARTRIDGES ARE EXPERIENCING (____?) ERRORS WHEN RUNNING AQC LEVEL 1 OR CVM LEVEL 1 OR 2. CUSTOMERS HAVE BEEN NOTIFIED ABOUT THIS SITUATION. URGENT FIELD SAFETY NOTICE 31512 REV A WAS ISSUED FOR DISTRIBUTION ON 27 MAY 2014. NEW FORMULATION OF SENSOR HAS BEEN RELEASED TO THE FIELD AND CARTRIDGES FROM SERIAL NUMBER (B)(4) SHOULD NOT EXPERIENCE THIS ISSUE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE RP500 INSTRUMENTS DISPLAYED QUESTION VALUES [...?] FOR SOME ANALYTES ON SOME PATIENTS SAMPLES AND DURING CVM/QC MEASUREMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349633 | RAPIDPOINT 500 | RP 500 | CHL | SIEMENS HEALTHCARE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |