MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-05-20 for RAPIDPOINT 405 10320055 manufactured by Siemens Healthcare Diagnostics.
[5855742]
Customer restored failed automatic quality control (aqc) parameters and run patient samples on the instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[13332223]
Customer should not have restored failed aqc parameters and run patient samples. Siemens representative guided customer to change some of the operators to level 3 and changed the system security access to restricted mode so that operators can only run sample, replace carts and access the recall menu but can not restore qc. The event has occurred due to an operator error. Instrument is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2015-00061 |
| MDR Report Key | 4784790 |
| Report Source | 06,07 |
| Date Received | 2015-05-20 |
| Date of Report | 2015-04-26 |
| Date of Event | 2015-04-21 |
| Date Mfgr Received | 2015-04-26 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | RAPIDPOINT 405 |
| Generic Name | RP 405 |
| Product Code | GKR |
| Date Received | 2015-05-20 |
| Catalog Number | 10320055 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-20 |