MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-06 for CLINITEK STATUS+ ANALYZER CT STATUS+ manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[2567238]
Customer reported instrument is reporting 20% hcg results as borderline as well as 2 false positive results. Delay in procedure to insert iud until serum test confirmed negative hcg result. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9535074]
Clinitest hcg lot identified by customer (b)(6) has been recalled by mfr and customer notified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00053 |
| MDR Report Key | 2412886 |
| Report Source | 07 |
| Date Received | 2012-01-06 |
| Date of Report | 2011-12-12 |
| Date of Event | 2011-12-12 |
| Date Mfgr Received | 2011-12-12 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-07-31 |
| 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 | 2012-01-06 |
| 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 | NORTH ROAD SUDBURRY, SUFFOLK C0106DX UK C010 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-06 |