MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for SIEMENS VISTA 1500 manufactured by Siemens Healthcare Diagnostics, Inc..
[31363030]
Patient Sequence No: 1, Text Type: N, H10
[31363031]
Female patient presents to the emergency department. Lab orders received at 18:24 including salicylate. Lab value for salicylate is 67. 6 mg/dl. A few days later hospitalist contacts pathologist for approval to send a sample for salicylate testing to reference lab (b)(6), as the patient was not responding to treatment as anticipated. Sample sent to (b)(6) in late evening with routine courier pickup. Three days later after sample sent to (b)(6), the technologist receives salicylate result from (b)(6), < 5 mg/dl. She recognizes that the patient had a toxic level reported from our lab from (b)(6) 2015 (result = 46. 6 mg/dl) and a result of 35. 2 on (b)(6) 2015. She tried to reach dr by paging. She asks another technologist to investigate (b)(6)'s salicylate method. They find the assay within our lab to be performing as expected with qc. The original sample sent from (b)(6) 2015 admission to (b)(6) for testing. Technologist obtained technical information on the abbott architect multiagent salicylate assay and noted no interferences. Technologist obtains information on potential interferences for the siemens salicylate method. Technologist hands off paperwork to manager in the afternoon. Issue with interfering agent was reported to siemens and "escalated". Frozen serum samples have been saved for testing, however manufacturer reports they do not have a mechanism for further investigating issues like the one we experienced with salicylates because there are too many new medications to keep up with. More detailed information about the event and all follow-up and additional testing completed is available upon request. Per mfr's response to hospital: siemens does not have a mechanism for further investigating issues like the one we experienced with salicylates because there are too many new medications to keep up with.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5229127 |
| MDR Report Key | 5229127 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-07-28 |
| Report Date | 2015-10-21 |
| Date Reported to FDA | 2015-10-21 |
| Date Reported to Mfgr | 2015-10-21 |
| Date Added to Maude | 2015-11-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS VISTA 1500 |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | DKJ |
| Date Received | 2015-11-17 |
| ID Number | DV310896 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 500 GBC DR. P.O. BOX 6101 NEWARK, DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-17 |