MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-31 for CLINITAK STATUS 10332185 manufactured by Siemens Healthcare Diagnostics Inc..
[4010100]
Customer reported negative leukocytes results on the instrument. Customer indicated that they run quality control after testing pt sample on the instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11255594]
Customer is being explanted for proper sample technique. Based on the discussion with customer, siemens representative found out that customer was on azo which can affect the readability of the test pads. Instrument is operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00200 |
| MDR Report Key | 3488861 |
| Report Source | 07 |
| Date Received | 2013-10-31 |
| Date of Report | 2013-10-08 |
| Date of Event | 2013-09-08 |
| Date Mfgr Received | 2013-10-08 |
| Date Added to Maude | 2013-12-30 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | NORTHERN ROAD, CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY, SUFFOLK CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITAK STATUS |
| Generic Name | CT STATUS |
| Product Code | JIR |
| Date Received | 2013-10-31 |
| Catalog Number | 10332185 |
| 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 | 2013-10-31 |