MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-04 for ADVIA 2120I WITH AUTOSAMPLER 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[21362538]
User error caused the event. Siemens healthcare diagnostics states in the instructions for use - directions for cleaning the centering collars that: to avoid personal injury and exposure to a potential biohazard, you must cover the needle with the red needle cover immediately after you remove the centering collar. Be careful not to bend the needle as you slip the cover over it. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[21419986]
Customer reported grazing her finger while swapping out the centering collars on the advia 2120i with autosampler. The customer failed to place a cover over the needle during this operation. The customer had a needle screen drawn and cleaned her finger with alcohol and soapy water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2013-00003 |
| MDR Report Key | 2897622 |
| Report Source | 05,06 |
| Date Received | 2013-01-04 |
| Date of Report | 2012-12-10 |
| Date of Event | 2012-12-10 |
| Date Mfgr Received | 2012-12-10 |
| Device Manufacturer Date | 2008-10-27 |
| Date Added to Maude | 2013-01-04 |
| 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 | MR. MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I WITH AUTOSAMPLER |
| Generic Name | COUNTER, CELL, AUTOMATED (PARTICLE COUNTER) |
| Product Code | GKL |
| Date Received | 2013-01-04 |
| Model Number | ADVIA 2120I |
| Catalog Number | 067-A004 |
| Lot Number | NA |
| 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 | 1. Other | 2013-01-04 |