MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-09 for CLINITEK ADVANTUS 10282611 manufactured by Siemens Healthcare Diagnostics Inc..
[3595142]
Customer reported a negative white blood cell (wbc) result on the instrument and visually with the multistix 10sg strip whereas microscopic result was positive. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5
[10905090]
The cause for the discordant white blood cell (wbc) results is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00120 |
| MDR Report Key | 3229820 |
| Report Source | 07 |
| Date Received | 2013-07-09 |
| Date of Report | 2013-06-19 |
| Date of Event | 2013-06-17 |
| Date Mfgr Received | 2013-06-19 |
| Date Added to Maude | 2013-07-22 |
| 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 ELECRONICS POLAND SP.Z O.O |
| Manufacturer Street | UL. POZENANSKA 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 | CLINITEK ADVANTUS |
| Product Code | CDM |
| Date Received | 2013-07-09 |
| Catalog Number | 10282611 |
| 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 | TARRYTOWN NY 10591509 US 10591 5097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-09 |