MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-02-24 for ADVIA CENTAUR * manufactured by Bayer Diagnostics Mfg. Ltd..
[16766530]
In 2005, a pt with methicillin resistant staphaureis was tested for vancomycin on an advia centaur by the hospital laboratory, the initial result was >90 ug/ml. Based on this result further pt treatment with the antibiotic vancomycin was withheld. The hospital continued to observe the pt and to monitor vancomycin levels, a retest the next day gave a result of 70. 2 ug/ml. All quality control was in range and all indications were that the system was performing as expected. Because the vancomycin levels had not gone down as expected. The hospital laboratory sent the samples to a reference laboratory for testing with an alternative method. The alternative method at the reference laboratory resulted in a 5. 7 ug/ml for the sample drawn on first. In addition, the hospital laboratory ran dilutions at 1:5 and 1:3 which gave results of 19. 85 ug/ml and 25. 77 ug/ml respectively. At this time the laboratory pathologist suspected heterophilic antibody interference and the initial samples were sent to bayer's laboratories for further analysis. Further testing at bayer's laboratories confirmed the observations at the hospital laboratory and a possible presence of a heterophilic antibody inteferent. The instructions for use for the vancomycin assay on the advia centaur indicate heterophilic antibody interference as a limitation of the assay. For medical device reporting purposes this event is considered closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2005-00003 |
| MDR Report Key | 576004 |
| Report Source | 05,06 |
| Date Received | 2005-02-24 |
| Date of Report | 2005-01-28 |
| Date of Event | 2005-01-26 |
| Date Added to Maude | 2005-02-28 |
| 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 AVE |
| 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 | 2005-02-24 |
| Model Number | ADVIA CENTAUR |
| 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 | 565854 |
| 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 | 2005-02-24 |