Brand Name | CLINITEK STATUS+ |
Type of Device | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
511 benedict avenue |
tarrytown NY 10591 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
northern road |
chilton industrial estate |
sudbury CO10 2XQ |
UK
CO10 2XQ
|
|
Manufacturer Contact |
thomas
myers
|
2 edgewater drive |
norwood, MA 02062
|
|
MDR Report Key | 16736532 |
MDR Text Key | 313328408 |
Report Number | 3002637618-2023-00020 |
Device Sequence Number | 1 |
Product Code |
JIL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K091216 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/13/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 10379675 |
Device Lot Number | 207024 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/05/2023
|
Initial Date FDA Received | 04/13/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |