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 2018-04-12 for CLINITEK STATUS+ 10379675 manufactured by Siemens Healthcare Diagnostics.
[105416059]
The customer stated that repeat testing was performed to confirm correct results which met the medical opinion and a corrected report was issued. Siemens reviewed cleaning, maintenance and proper technique for testing, with the customer. The customer was not cleaning the calibration bar. The qc is now in the expected ranges.
Patient Sequence No: 1, Text Type: N, H10
[105416060]
The customer reported a (b)(6) urine hcg on the clinitek status+ and (b)(6) serum quant. Hcg on another lab analyzer (unknown). There is no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2018-00045 |
| MDR Report Key | 7426936 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-03-30 |
| Date Added to Maude | 2018-04-12 |
| 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+ |
| Generic Name | CLINITEK STATUS+ |
| Product Code | LCX |
| Date Received | 2018-04-12 |
| Catalog Number | 10379675 |
| 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+ |
| Generic Name | CLINITEK STATUS+ |
| Product Code | JIL |
| Date Received | 2018-04-12 |
| 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 | 2018-04-12 |