MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-07 for ADVIA 2120 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[15582824]
Discordant cbc (complete blood count) results were obtained with 2 patient samples on an advia 2120 analyzer, sn (b)(4). The laboratory questioned the initial results for both patients, and the samples were run on the laboratory's other advia 2120 analyzer. The discordant cbc results for these patients were not reported to the physicians. There were no known reports of patient treatment being delayed, altered, or prescribed. There were no known reports of adverse health consequences due to the discordant cbc results.
Patient Sequence No: 1, Text Type: D, B5
[15870230]
A siemens healthcare diagnostics inc. Fse (field service engineer) was dispatched to the customer site for instrument evaluation. After evaluating the instrument and instrument data, the fse replaced the selector valve, and aligned and calibrated it. The fse also cleaned the perox vsc (vacuum shuttle chamber), ran qc material and adjusted the gains and calibration. The fse concluded that the cause of the discordant cbc results was due to a malfunctioning selector valve. The qc results were in range. The instrument is performing according to specifications. No further evaluation of the system is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00189 |
| MDR Report Key | 2362360 |
| Report Source | 05,06 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-11-10 |
| Date of Event | 2011-11-09 |
| Date Mfgr Received | 2011-11-10 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2012-07-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE SWORDS |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2011-12-07 |
| Model Number | ADVIA 2120 |
| 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 | 2011-12-07 |