MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-12-09 for CLINITEK STATUS+ ANALYZER CT STATUS+ manufactured by Siemens Healthcare Diagnostics, Manufacturing Ltd..
[2568779]
False negative hcg reported for clinitest hcg. No injury or harm to patient was reported. No serum sample run. Patient mammogram cancelled.
Patient Sequence No: 1, Text Type: D, B5
[9534643]
Patient came to facility and reported a positive home pregnancy result. Technician tested the patient using a manual unknown method with a result of "faint positive". Facility reported that controls were run after the clinitest negative result and controls were acceptable. Repeat sample on clinitek status result positive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00045 |
| MDR Report Key | 2414762 |
| Report Source | 07 |
| Date Received | 2011-12-09 |
| Date of Report | 2011-10-20 |
| Date of Event | 2011-10-20 |
| Date Mfgr Received | 2011-10-20 |
| Date Added to Maude | 2012-07-23 |
| 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 |
| 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 | 2011-12-09 |
| 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 RD. SUDBURY, SUFFOLK CO106DX UK CO10 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-09 |