MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-04-10 for CLINITEK STATUS+ USA 10379675 manufactured by Siemens Healthcare Diagnostics.
[105421516]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. The reagent has been requested to be sent back to siemens for investigation. The cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[105421517]
The customer reported a false negative hcg result on the clinitek status+ and a positive serum beta hcg at the hospital lab. On the same day that the negative hcg results were reported, the patient was given an injection of depo birth control. The patient is pregnant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2018-00042 |
| MDR Report Key | 7418102 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-04-17 |
| 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+ USA |
| Generic Name | CLINITEK STATUS+ |
| Product Code | LCX |
| Date Received | 2018-04-10 |
| Catalog Number | 10379675 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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+ USA |
| Generic Name | CLINITEK STATUS+ |
| Product Code | JIL |
| Date Received | 2018-04-10 |
| Catalog Number | 10379675 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |