MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-06 for RAPIDCOMM 10379871 manufactured by Simens Healthcare Diagnostics.
[4209440]
Customer reported that they scanned incorrect patient barcode and sample was run and transferred to lis (data management system). There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11687583]
The event has occurred due to an operator error. Customer indicated that the mistake was corrected quickly and there was no report of incorrect treatment. Instrument and data management system is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00008 |
| MDR Report Key | 3628051 |
| Report Source | 07 |
| Date Received | 2014-02-06 |
| Date of Report | 2014-01-10 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-10 |
| Date Added to Maude | 2014-03-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIMENS HEALTHCARE DIAGNOSTICS APC |
| Manufacturer Street | 800 TRADEPORT BLVD. |
| Manufacturer City | ATLANTA GA 30354 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30354 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDCOMM |
| Generic Name | RAPIDCOMM |
| Product Code | LMD |
| Date Received | 2014-02-06 |
| Catalog Number | 10379871 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-06 |