MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-16 for RAPIDPOINT 405 10320055 manufactured by Siemens Healthcare Diagnostics.
[26492388]
Customer should not have run patient sample when aqc turned off. Siemens representative sent operators manual to customer and referred her to selecting system security on pages 6-45 through 6-47. Customer indicated that they will review the security settings then decide which one works best for their lab. The event has occurred due to an operator error.
Patient Sequence No: 1, Text Type: N, H10
[26492389]
Customer reported that they run 7 patient samples when automatic quality control (aqc) was turned off. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2015-00133 |
| MDR Report Key | 5082968 |
| Date Received | 2015-09-16 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-08-12 |
| Date Mfgr Received | 2015-08-18 |
| Date Added to Maude | 2015-09-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | RAPIDPOINT 405 |
| Generic Name | RP 405 |
| Product Code | GKR |
| Date Received | 2015-09-16 |
| Catalog Number | 10320055 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-09-16 |