MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-14 for CLINITEK NOVUS 10697937 manufactured by Siemens Healthcare Diagnostics.
[145264777]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture. Siemens has submitted a request for additional information to properly assess the issue, but to date, most of the responses have not been received. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[145264778]
The customer reported falsely depressed leukocytes on the clinitek novus when compared to the microscopic examination of the urine sediment. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2019-00057 |
| MDR Report Key | 8609857 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 6107052212 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY, 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 NOVUS |
| Generic Name | CLINITEK NOVUS |
| Product Code | KQO |
| Date Received | 2019-05-14 |
| Catalog Number | 10697937 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-14 |