MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-29 for ADVIA 2120I 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[2450433]
A discordant wbc (white blood cell) count was obtained with one (1) patient samples on an advia 2120i analyzer. The customer did a study in which the four (4) of the patient's samples were run on different advia 2120i analyzers at 2 different laboratories. The customer considered the wbc count from the advia 2120i analyzer at their site (sn (b)(4)) to be discordant with the wbc counts obtained for this patient using 2 other advia 2120i analyzers at another laboratory. The wbc count results were not used to diagnose or treat the patient. There were no known reports of patient treatment being delayed, altered, or prescribed due to the discordant wbc count results. There were no known reports of adverse health consequences due to the discordant wbc count.
Patient Sequence No: 1, Text Type: D, B5
[9734476]
The customer contacted the technical solutions center (tsc) regarding this event. The cause of the discordant wbc results is unknown. 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 | 2432235-2011-00215 |
| MDR Report Key | 2392351 |
| Report Source | 05,06 |
| Date Received | 2011-12-29 |
| Date of Report | 2011-12-08 |
| Date of Event | 2011-12-06 |
| Date Mfgr Received | 2011-12-08 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2012-07-27 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2011-12-29 |
| Model Number | ADVIA 2120I |
| 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 | 2011-12-29 |