MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-07-14 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.
[6056909]
Customer indicated that on (b)(6) 2015, they had a blood gas sample that typed in the wrong patient id and the wrong patient name was assigned to the sample. The patient id typed in was (b)(6) and the patient name came up as (b)(6) and the correct patient id was supposed to be (b)(6) and patient name (b)(6). Customer indicated that the sample was run and the results were sent to rapidcomm (data management system). Customer indicated that they wanted to fix the error both in the analyzer and rapidcomm. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[13770319]
Customer indicated that they took the printout and looked at it and the operator realized her error and wrote the right name on the paper. Customer reported correct results to the doctor. Customer indicated that they wanted to fix the error both in the analyzer and rapidcomm. Siemens representative had customer go to the analyzer and go to recall patient and had him highlight the patient id that was entered incorrectly, had him type in the correct patient id and press the green arrow. The patient name is now correct. The issue has been resolved. The event has occurred due to an operator error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2015-00100 |
| MDR Report Key | 4912886 |
| Report Source | 06,07 |
| Date Received | 2015-07-14 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-06-14 |
| Date Mfgr Received | 2015-06-17 |
| Date Added to Maude | 2015-08-06 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | RAPIDPOINT 405 |
| Generic Name | RP 405 |
| Product Code | GKR |
| Date Received | 2015-07-14 |
| Catalog Number | 10322347 |
| 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 | 2015-07-14 |