MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-30 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[2130131]
Customer reports a false positive urine hcg on a patient. Repeat testing on same sample was negative. No unnecessary medical procedure was performed. No treatment was withheld as a result of this incident. There was no impact to patient health.
Patient Sequence No: 1, Text Type: D, B5
[9147273]
Instrument returned to manufacturer for investigation. Service personnel observed debris inside instrument and optics out of alignment. Customer is using replacement instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00020 |
| MDR Report Key | 2192575 |
| Report Source | 07 |
| Date Received | 2011-06-30 |
| Date of Report | 2011-06-03 |
| Date of Event | 2011-06-03 |
| Date Mfgr Received | 2011-06-03 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-05-15 |
| 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 02062CO1 |
| Manufacturer Country | UK |
| Manufacturer Postal Code | 02062 CO10 |
| 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 | 2011-06-30 |
| Model Number | CT STATUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-06-30 |