MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-20 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Medical Solutions Diagnostics, Ltd..
[1903304]
Received a report of a pt urine on (b)(6) 2011, which tested negative for hcg. Subsequent serum on same pt tested positive. The pt's treatment was not affected by the urine test result. No treatment was provided or denied prior to the serum test outcome.
Patient Sequence No: 1, Text Type: D, B5
[8864054]
Customer reported that qc runs daily were within range. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00001 |
| MDR Report Key | 1974565 |
| Report Source | 07 |
| Date Received | 2011-01-20 |
| Date of Report | 2011-01-06 |
| Date of Event | 2011-01-05 |
| Date Mfgr Received | 2011-01-06 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2012-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD |
| Manufacturer Street | NORTHERN RD |
| Manufacturer City | SUDBURY, SUFFOLK CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS ANALYZER |
| Generic Name | CLINITEK STATUS ANALYZER |
| Product Code | LCX |
| Date Received | 2011-01-20 |
| Model Number | CT STATUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. |
| Manufacturer Address | NORTHERN RD SUDBURY, SUFFOLK CO106DX UK CO10 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-20 |