MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-02 for ADVIA 2120I WITH AUTOSAMPLER 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[3258840]
(b)(6) has reported problems pertaining to mean corpuscular volume (mcv) assay performance on the siemens advia 2120i hematology analyzer. Physicians have stated that the mcv's reported by siemens advia hematology 2120i instruments were falsely elevated. (b)(6) internal investigation determined mcv results were 3-4 femtoliter (fl) higher since 2011. There are no reports of adverse health consequences due to the elevated mcv results.
Patient Sequence No: 1, Text Type: D, B5
[10608014]
Siemens investigated the mcv reported issue. The customer complaint was evaluated and the device was found to be performing within specification. Studies conducted by siemens have confirmed the accuracy of calibration of advia hematology instruments when compared to the clsi standard method for microhematocrit. In addition, a comparative study to another competitive hematology instrument in routine use at the customer lab showed that the two systems compared very closely with a 1. 4 femtoliter difference between the mcv results. The observed difference is well within the expected difference for mcv between two hematology systems in a comparative study. This mdr is being filed in response to user facility medwatch (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00106 |
| MDR Report Key | 3031635 |
| Report Source | 05,06 |
| Date Received | 2013-04-02 |
| Date of Report | 2013-03-08 |
| Date of Event | 2012-04-02 |
| Date Mfgr Received | 2013-03-08 |
| Device Manufacturer Date | 2009-10-27 |
| Date Added to Maude | 2013-05-31 |
| 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 | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE SWORDS |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I WITH AUTOSAMPLER |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2013-04-02 |
| Model Number | ADVIA 2120I |
| Catalog Number | 067-A004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-04-02 |