MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-07-30 for CLINITEK STATUS 10379675 manufactured by Siemens Healthcare Diagnostics Inc.
[3622268]
Customer reported negative urine results for white blood cells (wbc) and blood on the instrument but the visual results were positive for both white blood cells and blood. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5
[10977626]
The cause for the discordant white blood cells (wbcs) and blood results is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00142 |
| MDR Report Key | 3263985 |
| Report Source | 99 |
| Date Received | 2013-07-30 |
| Date of Report | 2013-07-01 |
| Date of Event | 2013-05-01 |
| Date Mfgr Received | 2013-07-01 |
| Date Added to Maude | 2013-08-15 |
| 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 | STEVE ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | BAYER HEALTHCARE, LLC |
| Manufacturer Street | 430 S. BEIGER STREET |
| Manufacturer City | MISHAWAKA IN 46546 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46546 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS |
| Generic Name | CT STATUS |
| Product Code | JIR |
| Date Received | 2013-07-30 |
| Catalog Number | 10379675 |
| 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 INC |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-30 |