MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-16 for ADVIA 2120 WITH AUTOSAMPLER manufactured by Siemens Healthcare Diagnostics Inc..
[19595738]
A siemens healthcare diagnostics inc. Field service engineer (fse) was dispatched to the customer site for instrument evaluation. After evaluating the instrument, the fse found that the power to the hemoglobin lamp was low. The fse adjusted the lamp's baseline reading to 3. 9, and ran qc material and obtained acceptable results. The fse also ran patient samples (in triplicate) using the auto-sampler mode and compared the hgb and hct results to those generated on another hematology analyzer. The hgb and hct results were consistent among the 3 replicates and matched those from the other analyzer. The cause of the discordant low hgb and hct results is unknown. No conclusions can be drawn as to what specifically caused the discordant hgb and hct results. The instrument is performing according to specifications. No further evaluation of the instrument is required.
Patient Sequence No: 1, Text Type: N, H10
[19678369]
Discordant low hemoglobin (hgb) and hematocrit (hct) results were obtained with one (1) patient sample tested on an advia 2120 analyzer using the auto-sampler mode. The initial discordant low hgb and hct results were reported to the physician. The low results were questioned due to the patient's history, and the sample was retested on the same analyzer, also using the auto-sampler mode. A new sample was drawn from the patient, and hgb and hct were run using the manual open-tube sampler mode. A corrected report with the results from the new sample were reported to the physician. There are no known reports of patient treatment being altered, delayed, or withheld due to the discordant low hgb and hct results. There were no known reports of adverse health consequences due to the discordant low hgb and hct results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2012-00155 |
| MDR Report Key | 2576542 |
| Report Source | 05,06 |
| Date Received | 2012-05-16 |
| Date of Report | 2012-04-03 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2005-10-15 |
| Date Added to Maude | 2012-09-24 |
| 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 | BARBARA KVASNOSKY |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243658 |
| 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 2120 WITH AUTOSAMPLER |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-05-16 |
| Model Number | ADVIA 2120 |
| 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 | 2012-05-16 |