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 2020-02-10 for CLINITEK STATUS+ 10379675 manufactured by Siemens Healthcare Diagnostics.
[178665979]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. Siemens has requested the reagent be returned for investigation. Siemens service reviewed proper technique and cleaning and maintenance procedures. Qc is passing and operators are following proper technique. The customer stated no tests or procedures were delayed due to the discrepant result. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[178665980]
The customer reported a (b)(6) urine hcg result on the clinitek status+ when compared to a repeat on the same instrument, a repeat on another clinitek status+ and a serum quantitative result. There was no reported injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00002 |
| MDR Report Key | 9687788 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Model Number | 10379675 |
| Catalog Number | 10379675 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-10 |