MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-11-14 for CLINITEK STATUS+ manufactured by Siemens Healthcare Diagnostics.
[19596291]
Additional information has been requested form the customer so that manufacturer can investigate further.
Patient Sequence No: 1, Text Type: N, H10
[19727047]
Customer reported a false negative protein with multistix 10sg strips on a pt with glomerulonephritis. Results were reported to the physician. No injury was reported with the event. No treatment to pt was impacted as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2012-00059 |
| MDR Report Key | 2860295 |
| Report Source | 07 |
| Date Received | 2012-11-14 |
| Date of Report | 2012-10-16 |
| Date of Event | 2012-10-16 |
| Date Mfgr Received | 2012-10-16 |
| Date Added to Maude | 2012-12-21 |
| 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 | SUBDURY, 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+ |
| Generic Name | CT STATUS+ |
| Product Code | LJX |
| Date Received | 2012-11-14 |
| 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 |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-14 |