MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for DNOTE CORE LICENSE 10732537 manufactured by Siemens Healthcare Diagnostics.
[105892750]
Siemens contacted the customer several times requesting additional information regarding this incident. The response from the customer was that they cannot provide any additional information on this issue.
Patient Sequence No: 1, Text Type: N, H10
[105892791]
The customer reported that a patient's glucose result was incorrectly reported verbally and insulin was given when it should not have been. The result was not on the patient's chart due to a procedural change initiated by the customer that did not get updated in the data management system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2018-00046 |
| MDR Report Key | 7429355 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-03-22 |
| Date Added to Maude | 2018-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 GMBH |
| Manufacturer Street | ALBERT-EINSTEIN-STR. 14 |
| Manufacturer City | BERLIN, 12489 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 12489 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DNOTE CORE LICENSE |
| Generic Name | DNOTE CORE LICENSE |
| Product Code | CFR |
| Date Received | 2018-04-13 |
| Catalog Number | 10732537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | DNOTE CORE LICENSE |
| Generic Name | DNOTE CORE LICENSE |
| Product Code | JQP |
| Date Received | 2018-04-13 |
| Catalog Number | 10732537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |