MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-30 for CLINITEK ADVANTUS 10282611 manufactured by Siemens Healthcare Diagnostics Inc.
[3402659]
Customer reported a false negative leukocyte on the instrument but the microscopic results were positive. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5
[10707625]
The cause of the discordant leukocyte results is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00072 |
| MDR Report Key | 3096513 |
| Report Source | 07 |
| Date Received | 2013-04-30 |
| Date of Report | 2013-04-18 |
| Date of Event | 2013-04-17 |
| Date Mfgr Received | 2013-04-18 |
| Date Added to Maude | 2013-05-13 |
| 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 | STEVE ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | KIMBALL ELECTRONICS POLAND SP.Z.O.O |
| Manufacturer Street | UL. POZNANSKA 1/C |
| Manufacturer City | TARNOWO PODGOME 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK ADVANTUS |
| Generic Name | CT ADVANTUS |
| Product Code | CDM |
| Date Received | 2013-04-30 |
| Catalog Number | 10282611 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-04-30 |