MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-10 for CLINITEK STATUS ANALYZER CT STATUS+ manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[2470989]
Customer reports multiple errant results with urine hcg testing including 3 false positive and 1 false negative. The false negative result was from a female who had an abortion 2 weeks prior to testing. Sample tested was grossly bloody (sample contained blood clots) and tested negative. Upon retesting on same instrument, sample tested positive. No injury was reported; however, pt who was informed that they were not pregnant because of the original false negative result was very upset and required a psychiatric eval.
Patient Sequence No: 1, Text Type: D, B5
[9582130]
Customer was advised not to test grossly bloody or turbid samples. Customer further advised that hcg is on hold at this time. Both lots identified in the report have been recalled by the mfr for potential false positive and borderline results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00055 |
| MDR Report Key | 2417545 |
| Report Source | 07 |
| Date Received | 2012-01-10 |
| Date of Report | 2011-12-15 |
| Date of Event | 2011-12-15 |
| Date Mfgr Received | 2011-12-15 |
| Date Added to Maude | 2012-08-01 |
| 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 | 2012-01-10 |
| 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 | NOTHERN ROAD SUDBURY, SUFFOLK CO106DX UK CO10 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-10 |