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 2019-05-30 for CLINITEK STATUS+ 10379675 manufactured by Siemens Healthcare Diagnostics.
[146542516]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. The poc coordinator inspected the calibration bar and found it to be dirty. The calibration bar was cleaned and the customer is confident that the instrument is operational and the discrepancy was due to a lack of maintenance. The customer stated that proper maintenance will be reviewed with the operators.
Patient Sequence No: 1, Text Type: N, H10
[146542537]
The customer reported a false negative urine hcg on the clinitek status+ when compared to an ultrasound and a seum hcg. There was no injury reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2019-00063 |
| MDR Report Key | 8654736 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-30 |
| 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 STATUS+ |
| Generic Name | CLINITEK STATUS+ |
| Product Code | JIL |
| Date Received | 2019-05-30 |
| Catalog Number | 10379675 |
| 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 | 2019-05-30 |