MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-03 for CLINITEK STATUS+ ANALYZER CT STATUS+ manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[21975094]
Manufacturer was unable to confirm any problems with the lot of reagent used by the customer. Customer has reported that they continue to use the instrument and it is operating as expected.
Patient Sequence No: 1, Text Type: N, H10
[22237920]
Customer reported false positive and false negative hcgs. Customer reported controls were within range. Depo-provera shots on pts were delayed until serum hcg results known. No unnecessary medical procedure was performed. No treatment was withheld as a result of this incident. There was no impact to pt health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2011-00040 |
| MDR Report Key | 2361262 |
| Report Source | 07 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-10-05 |
| Date of Event | 2011-09-08 |
| Date Mfgr Received | 2011-10-05 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2012-07-11 |
| 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 | LCX |
| Date Received | 2011-11-03 |
| 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 CO106DX UK CO10 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-03 |