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 120 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[15580360]
A discordant high hemoglobin (hgb) result was obtained with 1 patient sample on an advia 120 analyzer. Blood samples from a husband and wife were analyzed a few minutes apart. The wife's initial hgb result (which was flagged high by the system) was released to the physician. The laboratory questioned the wife's hgb result because it was elevated and nearly identical to the hgb result for her husband. The laboratory re-tested both samples manually. The manual testing yielded a markedly lower hgb result for the wife, and a result for the husband that matched his initial hgb result. (there were no discordant hgb results reported out for the husband. ) a fresh sample was re-drawn from the wife, and retested on the advia 120, which yielded a result that matched the manual repeat testing result. A corrected result was reported to the physician. 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 hgb results.
Patient Sequence No: 1, Text Type: D, B5
[15940476]
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 proactively adjusted the gains and calibration. The fse also cleaned the autosampler barcode reader, checked the alignment, and ran qc material. The fse concluded that the cause of the discordant hgb result was unknown. No conclusions can be drawn as to what caused the discordant high hgb result. 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 | 2432235-2011-00176 |
| MDR Report Key | 2362338 |
| Report Source | 05,06 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-11-09 |
| Date of Event | 2011-10-31 |
| Date Mfgr Received | 2011-11-09 |
| Device Manufacturer Date | 1999-06-15 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2011-12-07 |
| Model Number | ADVIA 120 |
| 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 |