MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-09-18 for RAPIDPOINT 405 10317193 manufactured by Siemens Healthcare Diagnostics.
[3853697]
Hold - sdacustomer reported that 2 patient demographics were inverted on the instrument. Customer indicated that patient information for a patient named "(b)(6).... " has been in the instrument since (b)(6) 2013 and associated with patient id (b)(6). Customer indicated that patient information for a patient named "(b)(6)... " has been in the instrument since (b)(6) 2013 and associated with patient id (b)(6). Customer reported that patient named "(b)(6)" was now associated with the patient id of the patient named "(b)(6)... ". This switch occurred sometime between (b)(6) 2013. There was no report of injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11373738]
The customer reported that the patients' initial results were input correctly into the instrument, and used for treatment decisions. Two weeks later, it was discovered that two patient id's had been inverted in the memory, and the names associated with those id's had been swapped. The cause for the error is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00167 |
| MDR Report Key | 3453306 |
| Report Source | 05,07 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-09-02 |
| Date of Event | 2013-08-24 |
| Date Mfgr Received | 2013-09-02 |
| Date Added to Maude | 2013-12-09 |
| 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 DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD |
| Manufacturer City | SUDBURY, SUFFOLK 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 | RAPIDPOINT 405 |
| Product Code | JIR |
| Date Received | 2013-09-18 |
| Catalog Number | 10317193 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-18 |