MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-12-13 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[2500349]
Customer reported a false positive hcg. The customer further reported that when sample was run on another analyzer, the result was negative. As a result of the positive test result, a patient treatment was cancelled. Customer also reported borderline and false positive results with a negative control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2011-00047 |
| MDR Report Key | 2387586 |
| Report Source | 07 |
| Date Received | 2011-12-13 |
| Date of Report | 2011-11-23 |
| Date of Event | 2011-11-23 |
| Date Mfgr Received | 2011-11-23 |
| Date Added to Maude | 2011-12-23 |
| 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 ROAD |
| Manufacturer City | SUDBURY, SUFFOLK C0102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | C010 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 | JHJ |
| Date Received | 2011-12-13 |
| Model Number | CT STATUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD. |
| Manufacturer Address | NORTHERN ROAD SUDBURY, SUFFOLK CO106DX UK CO10 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-13 |