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 2020-03-25 for CLINITEK STATUS+ UK 10379676 manufactured by Siemens Healthcare Diagnostics.
[187099134]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. Proper maintenance was reviewed with the customer and no issues were found. The calibration bar was clean and the qc passed. The device has been sent to siemens workshop for investigation and repair. Siemens has asked for the workshop report to be provided. The customer stated there was no harm to the patient. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[187099135]
The customer reported a false negative urine hcg on the clinitek status+. They repeated the urine test using a new sample and the result was positive. The hcg quantitative blood test was also positive. The customer stated that a grommet insertion - tube to prevent persistent fluid build up in the ear, was withheld. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00013 |
| MDR Report Key | 9879246 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 7052212 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS+ UK |
| Generic Name | CLINITEK STATUS+ |
| Product Code | JHI |
| Date Received | 2020-03-25 |
| Catalog Number | 10379676 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |