MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-12-23 for ADVIA CENTAUR * manufactured by Bayer Diagnostics Mfg. Ltd..
[15716935]
In 2005, the er doctors at a hosp questioned several troponin i results on the advia centaur analyzer. Qc material was run in the morning and all levels were in. Time: 07:18, level 1: 1. 492, level 2: 1. 827, level 3: 2. 954. Time: ranges, level 1: 1. 1-1. 9, level 2: 1. 4-2. 6, level 3: 2. 1-4. 1. When the results were questioned later that day, qc's were repeated on this analyzer and all levels were out of range. As a result of the earlier test results, one pt underwent a cardiac catheterization. Initial pt result = 1. 18 ng/ml. The samples and qc were run on a second centaur analyzer and the qc was in range and the samples were normal. Repeat pt result on 2nd instrument <0. 15 ng/ml. The other falsely elevated troponin i values did not result in pt interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2005-00019 |
| MDR Report Key | 656606 |
| Report Source | 05,06 |
| Date Received | 2005-12-23 |
| Date of Report | 2005-10-26 |
| Date of Event | 2005-10-20 |
| Date Mfgr Received | 2005-10-26 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2005-12-29 |
| 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 | 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.,SWORDS CO |
| Manufacturer Street | CHAPEL LN |
| Manufacturer City | DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR |
| Generic Name | IMMUNOASSAY SYSTEM |
| Product Code | LCI |
| Date Received | 2005-12-23 |
| 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 | 646092 |
| Manufacturer | BAYER DIAGNOSTICS MFG. LTD. |
| Manufacturer Address | CHAPEL LN DUBLIN, SWORDS CO 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 | 2005-12-23 |