MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-30 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[20915440]
Customer reports a false positive urine hcg result. Pt was scheduled for a surgical procedure that was cancelled. Serum test was negative for hcg.
Patient Sequence No: 1, Text Type: D, B5
[21147753]
Pt stated it was possible that she was pregnant. Reporting facility stated that the technician's technique may be a factor in the false positive result. Testing techniques and cleaning procedures were reviewed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00044 |
| MDR Report Key | 2379475 |
| Report Source | 07 |
| Date Received | 2011-11-30 |
| Date of Report | 2011-11-08 |
| Date of Event | 2011-11-07 |
| Date Mfgr Received | 2011-11-08 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2012-07-19 |
| 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 |
| 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 | LCX |
| Date Received | 2011-11-30 |
| Model Number | CT STATUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 C0106DX UK C010 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-30 |