MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-02-16 for ADVIA 120 * manufactured by Siemens Medical Solutions Diagnostics Manufacturing Ltd..
[15559876]
In 2007, the emergency room reported a discrepant hemoglobin (hgb) result of 8. 4 g/dl on the advia 120. The patient received a blood transfusion based on this result. Subsequent testing of the same sample gave a hgb result of 11. 3 g/dl. A field service engineer was sent to the site to inspect the instrument. He checked sampling in the autosampler and found a loose sample line from the autosampler to the selector valve. This autosampler hydraulic problem caused a dilution of both the hgb and rbc results, and the uniform dilution of both parameters did not generate a cc asterisk (warning flag). The engineer addressed the hydraulic issue by replacing the pathway from the autosampler aspirator to the selector valve. He also addressed a clogged centering collar and adjusted the conductivity voltage to specification. The instrument is now performing as intended. For medical device reporting purposes this event is considered closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2007-00006 |
| MDR Report Key | 822046 |
| Report Source | 05,06 |
| Date Received | 2007-02-16 |
| Date of Report | 2007-01-18 |
| Date of Event | 2006-12-30 |
| Date Mfgr Received | 2007-01-18 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2007-03-02 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | PHILIP LIU |
| Manufacturer Street | 511 BENEDICT AVE. |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | * |
| Manufacturer G1 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MFG. , LTD. |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, CO. DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY SYSTEM |
| Product Code | GLK |
| Date Received | 2007-02-16 |
| Model Number | ADVIA 120 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 809454 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Address | CHAPEL LANE SWORDS, CO. DUBLIN EI |
| Baseline Brand Name | ADVIA 120 |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K971998 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-16 |