MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-11-18 for COBAS INTEGRA 400 I400 21045199001 manufactured by Roche Diagnostics.
[1253541]
The user stated they have had "at least 5 occurrences" of a high hemoglobin a1c result which was reported, then repeated as normal. The doctors have stated the patients with the high results have no other indication that would cause a high result. The patients had not been treated as "the doctors felt the patients had not been that high and notified the lab, resulting in the repeat testing. " the user provided three examples. On (b)(6)2009, a sample for a female patient resulted 13. 6% initially and 7. 56% upon repeat. On (b)(6)2009, a sample for a female pt resulted 11. 8% initially and 6. 2% upon repeat. On (b)(6)2009, a sample for a male patient resulted 14. 1% initially and 7. 4% upon repeat. The field service representative could not find a cause and checked the analyzer by performing pipetting and photometer checks with acceptable results. He also checked the configuration of the assay and ran eight specimens and could not duplicate the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-07905 |
| MDR Report Key | 1553454 |
| Report Source | 05,06 |
| Date Received | 2009-11-18 |
| Date of Report | 2009-11-18 |
| Date of Event | 2009-10-08 |
| Date Facility Aware | 2009-10-29 |
| Report Date | 2009-10-29 |
| Date Mfgr Received | 2009-10-29 |
| Date Added to Maude | 2010-04-30 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | 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 400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | LOP |
| Date Received | 2009-11-18 |
| Model Number | I400 |
| Catalog Number | 21045199001 |
| 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 | 2009-11-18 |