MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-27 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[74156320]
A siemens customer service engineer (cse) was dispatched to the customer's site. The cse checked the alignment of the aliquot probe, resulting within specifications. The cse noticed the sample cup with barcode was misplaced on the rack. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[74156321]
Customer reported experiencing a three hour delay for c-reactive protein newborn patient sample on a dimension vista 1500 instrument. The initial result was not reported out to the physician(s) due to an instrument malfunction. The instrument malfunction caused a puncture in the sample cup. Due to the puncture, the patient was re-drawn and tested. The customer reported out the re-drawn sample result to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the three hour delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00464 |
| MDR Report Key | 6528586 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-27 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2009-05-29 |
| Date Added to Maude | 2017-04-27 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION NUMBER: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-04-27 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-27 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-27 |