MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-09-21 for ADVIA 2120 WITH DUAL ASPIRATE 067-A011-02 manufactured by Siemens Healthcare Diagnostics Inc..
[20105450]
The customer reported that an advia 2120 with dual aspirate instrument barcode reader misread a barcode. Barcode 08213061300 was read as 08213060300. There were no reports of adverse health consequences or known patient intervention due to the misread barcode.
Patient Sequence No: 1, Text Type: D, B5
[20166218]
The customer contacted the siemens technical solutions center (tsc) regarding this event. The tsc evaluated the data and determined that the cause of the misread barcode symbology was user error. The tsc determined that the customer was using codabar symbology, that is not recommended by siemens as per the barcode selection in the operator's guide. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
[26377909]
The initial mdr 1226181-2013-00453 was filed on october 21, 2013. Additional information (09/27/2013): the number for the urgent medical device correction and urgent field safety notice "dimension vista 500/dimension vista 1500 user defined method flex assignment" is 13-77.
Patient Sequence No: 1, Text Type: N, H10
[34110363]
The initial mdr 2432235-2013-00453 was filed on september 21, 2013. Supplemental mdr 2432235-2013-00453_s1 was filed on october 22, 2013. Correction: (b)(4). Supplemental mdr 2432235-2013-00453_s1 corresponds to the initial mdr 1226181-2013-00453, not mdr 2432235-2013-00453.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00453 |
| MDR Report Key | 3361270 |
| Report Source | 01,05,06 |
| Date Received | 2013-09-21 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-21 |
| Date Mfgr Received | 2014-02-21 |
| Device Manufacturer Date | 2004-09-21 |
| Date Added to Maude | 2013-12-19 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE SWORDS |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120 WITH DUAL ASPIRATE |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2013-09-21 |
| Model Number | ADVIA 2120 WITH DUAL ASPIRATE |
| Catalog Number | 067-A011-02 |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-21 |