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 2018-04-10 for CLINITEK STATUS+ FRANCE 10379678 manufactured by Siemens Healthcare Diagnostics.
[105438081]
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued. Siemens has requested the reagent to be sent back for investigation. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[105438082]
The customer reported a false negative urine hcg result on the clinitek status and a positive serum result 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 | 3002637618-2018-00043 |
| MDR Report Key | 7418514 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-03-30 |
| Date Added to Maude | 2018-04-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| 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+ FRANCE |
| Generic Name | CLINITEK STATUS+ |
| Product Code | LCX |
| Date Received | 2018-04-10 |
| Catalog Number | 10379678 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | CLINITEK STATUS+ FRANCE |
| Generic Name | CLINITEK STATUS+ |
| Product Code | JIL |
| Date Received | 2018-04-10 |
| Catalog Number | 10379678 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-04-10 |