MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-31 for RAPIDCOMM 10318763 manufactured by Siemens Healthcare Diagnostics Inc..
[4027293]
Customer reported that rapidcomm (data management system) displayed erroneous pt demographics. Customer indicated that when they scanned the pt visit number # (b)(6), it was identified correctly on the analyzer as pt # 1 and sent info to data management system but data management system erroneously displayed pt # 2 demographics with same visit # (b)(6). There was no injury reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11255173]
This event is occurred due to an operator error. Based on the discussion with customer, the siemens representative found out that side was using a non-unique valve in a field which is required to be unique. Additionally the incorrect demographics returned were accepted by the operator. Instrument is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00195 |
| MDR Report Key | 3488840 |
| Report Source | 07 |
| Date Received | 2013-10-31 |
| Date of Report | 2013-10-07 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2013-10-07 |
| Date Added to Maude | 2013-12-30 |
| 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 |
| 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 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 | 2013-10-31 |
| Catalog Number | 10318763 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-31 |