MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-26 for ADVIA 2120I 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[2343350]
Discordant results for hemoglobin were obtained on an advia 2120i instrument. The discordant low results were reported to the healthcare provider(s). The patient was prepped for a transfusion. The physician requested a re-test and cancelled the transfusion based on the re-run results. There were no reports of patient intervention or adverse health consequences.
Patient Sequence No: 1, Text Type: D, B5
[9317858]
A siemens global product support (gps) engineer analyzed the system data. Analysis of the sample results showed that the discordant sample was flagged by the system per specification as having a problem. It was determined that the cause of the event was user error. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00168 |
| MDR Report Key | 2309694 |
| Report Source | 05,06 |
| Date Received | 2011-10-26 |
| Date of Report | 2011-09-30 |
| Date of Event | 2011-09-26 |
| Date Mfgr Received | 2011-09-30 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2012-07-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2011-10-26 |
| Model Number | ADVIA 2120I |
| Catalog Number | 067-A004 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 2011-10-26 |