FDA Adverse Event
Other
Summary report: N
MULTISTIX 10SG STRIPS
MDR report key: 3601616
·
Received January 13, 2014
Report
- Report Number
- 1217157-2013-00260
- Event Type
- Other
- Date Received
- January 13, 2014
- Date of Event
- November 25, 2013
- Report Date
- December 20, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Product Code
- JIO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THEY RUN PATIENT SAMPLES EVEN WHEN THE QUALITY CONTROL (QC) FAILED. CUSTOMER SHOULD NOT HAVE RUN THE PATIENT SAMPLES WHEN QC WAS FAILED. CUSTOMER HAS BEEN PROVIDED WITH NEW BOTTLE OF MULTISTIX 10SG STRIPS. CUSTOMER INDICATED THAT THE ISSUE IS RESOLVED WITH A NEW LOT OF MULTISTIX 10SG STRIPS. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.
Description of Event or Problem · 1
CUSTOMER REPORTED 27 FALSE POSITIVE UROBILINOGEN RESULTS USING DETERIORATED MULTISTIX 10SG TEST STRIPS. CUSTOMER INDICATED THAT THEY HAVE BEEN RUNNING PATIENT SAMPLES ON THESE TEST STRIPS SINCE (B)(6) 2013. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23346 | MULTISTIX 10SG STRIPS | MULTISTIX 10SG | JIO | SIEMENS HEALTHCARE DIAGNOSTICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |