MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-03-17 for ADVIA CENTAUR * manufactured by Bayer Diagnostics Mfg. Ltd..
[373457]
In 2005 a pt was admitted to the hospital, original testing at 03:52 am resulted in a troponin valve of 1. 93 ng/ml and a ckmb of 4. 5. Controls run prior to the original test were out of range. The original results were reported to the physician even though the controls were out of range. Subsequent testing at 09:43 yielded results of <0. 10 ng/ml for troponin i and 0. 7 ng/ml for ckmb. Customer ran an aspirate 1 dispense test as indicated in the instructions for use to troublleshoot the instrument and discovered the aspirate cuvette overflowing. Upon this discovery the customer called bayer and a field engineer was dispatched. The field engineer inspected the instrument, flushed out the aspirate line and discovered a slight clog in the line. After troubleshooting the field engineer ran controls again and they were in range. On the 5th day bayer was notified by the hospital laboratory that the physician acted on the original results and the pt underwent a cardiac catheterization due to the initial elevated troponin result on the advia centaur. Bayer instructions for use indicate that if the quality control materials do not fall within the expected values or within the laboratory's expected values the operator should review the instructions for use to ensure the assay was performed according to the procedures recommended by bayer; verify that the materials are not expired; verify that required maintenance was performed and if necessary, rerun the quality control samples or contact bayer for more assistance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2005-00005 |
| MDR Report Key | 583256 |
| Report Source | 06 |
| Date Received | 2005-03-17 |
| Date of Report | 2005-02-18 |
| Date of Event | 2005-02-13 |
| Date Added to Maude | 2005-03-22 |
| 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 BENEDIC TAVENUE |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR |
| Generic Name | IMMUNOASSAY SYSTEM |
| Product Code | LCI |
| Date Received | 2005-03-17 |
| Model Number | ADVIA CENTAUR |
| 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 | 573084 |
| Manufacturer | BAYER DIAGNOSTICS MFG. LTD. |
| Manufacturer Address | CHAPEL LANE SWORDS CO., DUBLIN EI |
| Baseline Brand Name | BAYER CENTAUR SYSTEM |
| Baseline Generic Name | IMMUNOASSAY SYSTEM |
| Baseline Model No | ADVIA CENTAUR |
| Baseline Catalog No | 254 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-17 |