MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-21 for ADVIA 2120I 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[19417155]
The customer reported that an advia 2120i barcode reader misread a barcode. Barcode (b)(6) was read as (b)(6). 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
[19477035]
The customer contacted the siemens technical solutions center (tsc) regarding this event. Siemens evaluated the barcodes that were submitted by the country and determined the cause of the misread barcode was user error. 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
| Report Number | 2432235-2013-00097 |
| MDR Report Key | 3014919 |
| Report Source | 05,06 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-02-19 |
| Date of Event | 2013-02-14 |
| Date Mfgr Received | 2013-02-19 |
| Device Manufacturer Date | 2012-08-22 |
| Date Added to Maude | 2013-05-22 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| 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 2120I |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2013-03-21 |
| Model Number | ADVIA 2120I |
| Catalog Number | 067-A004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-03-21 |