MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-25 for CLINITEK ADVANTUS manufactured by Siemens Medical Solutions Diagnostics.
[21262834]
Customer reports false negative results for leukocytes on the instrument and as well as when the strip was read manually (visually). Microscopic exam revealed 15-50 leukocytes per field. There was no report to pt care as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[21270651]
The cause for the discordant sample is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00044 |
| MDR Report Key | 3031929 |
| Report Source | 07 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-03-06 |
| Date of Event | 2013-02-28 |
| Date Mfgr Received | 2013-03-06 |
| Date Added to Maude | 2013-04-12 |
| 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 | 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 | 2013-03-25 |
| Model Number | ADVANTUS |
| 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 MEDICAL SOLUTIONS DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-25 |