MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-03-02 for ADVIA 120 * manufactured by Bayer Diagnostics Mfg. Ltd..
[337798]
In 2/2004 a bayer technical service specialist reported that a customer had sent out an erroneous result for a pt's hemoglobin level that led to the pt being transfused. The hosp claims that a cbc differential was run on the advia 120 instrument, an initial result for hemoglobin of 8. 4 g/dl was reported. The results for some white blood cell (wbc) parameters for this sample were clearly flagged, but no red blood cell parameters were flagged so those results were reported. The lab reported that they did not repeat testing on the sample even though it flagged white blood cell counts because it is their practice to verify the wbc count with a smear count. Quality controls were within specifications. The pt was transfused with two units of blood based on the 8. 4 g/dl hemoglobin count. A post-transfusion sample gave a result of 16. 0 g/dl. The lab reran the pretransfusion sample and the hemoglobin result was 11. 5 g/dl. At this time errors associated with sample collection, handling and mixing cannot be ruled out. It is unknown what caused the event but the customer feels satisfied that the system is operating as specified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2004-00003 |
| MDR Report Key | 531074 |
| Report Source | 05,06 |
| Date Received | 2004-03-02 |
| Date of Report | 2004-02-04 |
| Date of Event | 2004-01-25 |
| Date Mfgr Received | 2004-02-04 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2004-06-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANDRES HOLLE |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243494 |
| Manufacturer G1 | BAYER DIAGNOSTIC MFG LTD |
| Manufacturer Street | * |
| Manufacturer City | DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY SYSTEM |
| Product Code | GLK |
| Date Received | 2004-03-02 |
| Model Number | ADVIA 120 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 520323 |
| Manufacturer | BAYER DIAGNOSTICS MFG. 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 | 2004-03-02 |