MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-08 for RAPIDCOMM 10697319 manufactured by Siemens Medical Solutions Diagnostics.
[4087172]
Customer reported that operator's id was erroneously scanned into a patient id field instead of scanning an account number into a patient id field. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11411220]
The event has occurred due to an operator error. Siemens representative instructed customer to change the data in the medical report number from the operator id to the desired account number. Patient demographic was successfully changed. Instrument is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00212 |
| MDR Report Key | 3472567 |
| Report Source | 07 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-10-14 |
| Date of Event | 2013-10-13 |
| Date Mfgr Received | 2013-10-14 |
| Date Added to Maude | 2013-12-24 |
| 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 | SIEMENS HEALTHCARE DIAGNOSITCIS 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 | 2013-11-08 |
| Catalog Number | 10697319 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-08 |