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 2020-02-28 for CLINITEK STATUS+ 10379675 manufactured by Siemens Healthcare Diagnostics.
[182564829]
The complaint preparer reviewed technique, cleaning and maintenance procedures with the customer. No errors were found with the technique. The customer states they are cleaning the calibration bar with alcohol. As per the system manual: "wet a new cotton-tipped stick or lint-free cloth with distilled water and gently wipe and clean the calibration bar. " they should not be using alcohol. The customer stated they have two clinitek status' and they are running patient samples on both instruments and comparing the results as a way to double check the instruments. They have not had any further discrepancies.
Patient Sequence No: 1, Text Type: N, H10
[182564830]
The customer reported a false negative qualitative urine hcg on the clinitek status+ when compared to three home pregnancy tests and a beta hcg quantitative test on a non-siemens lab analyzer. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00008 |
| MDR Report Key | 9771887 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS+ |
| Generic Name | CLINITEK STATUS+ |
| Product Code | JHI |
| Date Received | 2020-02-28 |
| Model Number | 10379675 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |