MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-22 for CLINITEK ADVANTUS manufactured by Siemens Healthcare Diagnostics.
[3154438]
Customer reports false negative leukocyte results on a sample which, upon microscopic exam, is 2+ positive for leukocytes. No report of injury with the event.
Patient Sequence No: 1, Text Type: D, B5
[10447889]
Customer reports they had never cleaned the system. Customer was provided instruction on proper cleaning and maintenance of the system. Customer was sent new lot of test strips and will perform correlation study. Mfr awaiting results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2012-00080 |
| MDR Report Key | 2931384 |
| Report Source | 07 |
| Date Received | 2013-01-22 |
| Date of Report | 2012-12-03 |
| Date of Event | 2012-12-03 |
| Date Mfgr Received | 2012-12-03 |
| Date Added to Maude | 2013-02-07 |
| 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 DRIVE |
| 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 ADVANTUS |
| Generic Name | CLINITEK ADVANTUS |
| Product Code | CDM |
| Date Received | 2013-01-22 |
| Model Number | ADVANTUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-22 |