MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-02 for CLINITEK STATUS manufactured by Siemens Healthcare Diagnostics, Inc..
[104039849]
Patient Sequence No: 1, Text Type: N, H10
[104039850]
The clinitek urine analyzer used to check urine for point-of-care testing (poct) had a positive result. The serum test used to check had results of < 1 miu/ml. The urine test was repeated showing borderline results. Another machine used showed negative results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7388068 |
| MDR Report Key | 7388068 |
| Date Received | 2018-04-02 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-18 |
| Report Date | 2018-03-21 |
| Date Reported to FDA | 2018-03-21 |
| Date Reported to Mfgr | 2018-03-21 |
| Date Added to Maude | 2018-04-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS |
| Generic Name | ANALYZER, HUMAN CHORIONIC GONADOTROPIN |
| Product Code | JHJ |
| Date Received | 2018-04-02 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 2 EDGEWATER DRIVE NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-02 |