MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-23 for ADVIA 2120 manufactured by Siemens Healthcare Diagnostics, Inc..
[2496792]
The operator of an advia 2120 analyzer was maintaining the analyzer when he cut his finger on the hand-retractable plunger of the autosampler aspiration assembly. It is unknown at this time if medical attention was sought for the cut on his hand. There are no reports of adverse health consequences due to the cut on the operator's hand.
Patient Sequence No: 1, Text Type: D, B5
[9576193]
The cause of the event is unknown at this time. This incident is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[10158353]
Siemens filed the initial mdr on (b)(4) 2011. (b)(4) 2012 additional information: siemens contacted the customer multiple times to follow up on the operator injury. The customer did not respond.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00209 |
| MDR Report Key | 2387495 |
| Report Source | 05,06 |
| Date Received | 2011-12-23 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-12-05 |
| Date Mfgr Received | 2012-08-23 |
| Device Manufacturer Date | 2007-05-03 |
| Date Added to Maude | 2011-12-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2011-12-23 |
| Model Number | ADVIA 2120 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-23 |