MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-23 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.
[16461382]
Customer reported that they scanned a patient id on the instrument and when it crossed over to rapidcomm it was a different patient id. Customer indicated that they caught the incorrect patient id and corrected the issue and they have not had any other similar issue ever since. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[16787036]
A review of both the rp405 log files and rapidcomm show the patient id entered in the rp405 system is the same one that was transmitted to rapidcomm. This shows that the patient id entered by the customer is the patient id transmitted. Sample order from rapid comm (b)(6) 2014 04:36 jxxxx baby girl 1 ((b)(6)) (b)(6) 2014 04:39 hxxxx baby boy ((b)(6)) (b)(6) 2014 04:49 hxxxx baby boy ((b)(6)) patients jxxxxx has baby 1 and baby 2 (twins); on (b)(6) 2014 jxxxxx baby 1 ((b)(6)) was tested @ 4:36 am but no jxxxxx baby 2 (patient id not provided). It was not until (b)(6) 4:52 am that jxxxxx baby 2 had a sample run (no data provided). The 3rd sample listed on (b)(6) @ 4:49 is the sample they initially believed should have been jxxxx baby 2 coming over but rapidcomm says it is patient hxxxxx ((b)(6)) and the system log (paz) file shows patient hxxxxx ((b)(6)) for both samples as well. Baby 1 jxxxx (1428400354) and baby hxxxxx ((b)(6)) were tested at about the same time on (b)(6) 2014 ~ 4:39; review of sample logs showed results for baby hxxxxx ((b)(6)) had a big change in sample results(ph and pco2) in <12 minutes. Ph/pco2 typically do not change this amount during a 12 minute span. This leads to further evidence there was a preanalytical sample labeling or scanning issue by the customer. Siemens customer complaint center team who worked with the customer to review the rapidcomm logs indicated that the customer did not want to investigate any further and will be looking at their internal practices with bar code labels. Instrument is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2015-00050 |
| MDR Report Key | 4724493 |
| Report Source | 06,07 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-03-29 |
| Date of Event | 2014-11-09 |
| Date Mfgr Received | 2015-03-29 |
| Date Added to Maude | 2015-05-22 |
| 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 | 2015-04-23 |
| Catalog Number | 10322347 |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-04-23 |