MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-01 for ADVIA 2120 manufactured by Siemens Healthcare Diagnostics, Inc..
[2656043]
Discordant high advia 2120 hemoglobin results were obtained on two patient samples the customer noticed that the controls were out of range and stopped using the instrument, however results had been sent to the physician(s) the samples were repeated on an alternate system and corrected reports were sent out. There is no known report of treatment given or withheld based on the discordant hemoglobin results.
Patient Sequence No: 1, Text Type: D, B5
[9890691]
A siemens fse (field service engineer) was dispatched to the customer site to evaluate the advia 2120 instrument. After analysis of the instrument the fse cleaned all the ports and changed the diaghram pumps. The instrument is performing within specifications. No further evaluation of the device is needed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00169 |
| MDR Report Key | 2595946 |
| Report Source | 05,06 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-05-22 |
| Date Mfgr Received | 2012-05-22 |
| Date Added to Maude | 2012-10-03 |
| 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 | MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMIT |
| Manufacturer Street | CHAPEL LANE, SWORDS, CO. |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-06-01 |
| Model Number | ADVIA 2120 |
| 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 | 2012-06-01 |