MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-12-12 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[2499430]
Customer reported 3 hcg false positives on one lot of reagents. One of the three patients had an iud removed due to the false positive result and must return to have the iud reinserted. The other two patients had a beta test done which was negative. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9576199]
All controls run during the time of the events were within range. Customer stated the instrument calibration bar was cleaned with soap and water. Manufacturer advised customer that calibration bar should only be cleaned with distilled water.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00049 |
| MDR Report Key | 2387562 |
| Report Source | 07 |
| Date Received | 2011-12-12 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-11-29 |
| Date Mfgr Received | 2011-11-29 |
| 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 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 | JHJ |
| Date Received | 2011-12-12 |
| 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 | NORTHER ROAD SUDBURY, SUFFOLK CO106DX UK CO10 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-12 |