MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-08 for COBAS INTEGRA 800 I800 28122474001 manufactured by Roche Diagnostics.
[1448985]
The user stated a physician questioned hemoglobin a1c results for at least 63 patient samples. The user performed precision testing with discrepant results. A precision run on qc material demonstrating the issue gave the following results: 13. 74, 13. 86, 13. 52, 14. 11, 9. 20, 13. 81, 13. 98, 13. 95, 13. 84, 13. 88 and 13. 64%. A precision test using a patient sample gave the following results: 18. 3, 18. 7, 19. 7, 18. 3, 17. 2, 18. 5, 18. 5, 17. 7, 18. 7 and 19. 3%. Patient data indicating discrepant results were generated was not provided. No erroneous patient results were reported. No patients were adversely affected. The field service representative determined, there was problem with the sr probe and replaced the probes and checked the syringes and cleaner dispense. He verified the analyzer operation by running precision testing, qc and patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-08270 |
| MDR Report Key | 1580789 |
| Report Source | 05,06 |
| Date Received | 2009-12-08 |
| Date of Report | 2009-12-08 |
| Date of Event | 2009-11-11 |
| Date Facility Aware | 2009-11-13 |
| Report Date | 2009-11-13 |
| Date Mfgr Received | 2009-11-13 |
| Date Added to Maude | 2010-05-08 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG |
| Manufacturer Street | TEGIMENTA FORRENSTRASSE |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | LOP |
| Date Received | 2009-12-08 |
| Model Number | I800 |
| Catalog Number | 28122474001 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-08 |