MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-24 for COBAS INTEGRA 800 28122474001 manufactured by Roche Diagnostics.
[1730953]
The user received a questionable result for phenytoin (phny) on the integra 800 analyzer for one patient sample. The initial result was 35. 75 ug/ml. This result was reported outside the laboratory. The doctor questioned the result and had the patient come back to the facility to be redrawn. This redraw sample was sent out to another laboratory for testing. The user said the phny result from this other laboratory was < linearity, essentially 0. 0 ug/ml. The actual result and instrument used for this testing was not provided. On (b)(6) 2010, the initial sample was repeated by the original instrument this yielded a result of < 0. 61 ug/ml. This result was accompanied by a data flag. The user said the patient was held in the facility due to suspicion of abuse of phenytoin. The user did not know when the patient was released from the facility or the patient's current condition. No adverse events have been reported regarding this event. The reagent lot number for phny was 62136201. Although the field service representative could not determine an exact cause, he found a small amount of white residue in the wash station tubing. Performance tests were run which were within specification.
Patient Sequence No: 1, Text Type: D, B5
[8845695]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-00343 |
| MDR Report Key | 1968330 |
| Report Source | 05,06 |
| Date Received | 2011-01-24 |
| Date of Report | 2011-01-24 |
| Date of Event | 2010-12-27 |
| Date Mfgr Received | 2010-12-29 |
| Date Added to Maude | 2011-04-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2011-01-24 |
| Model Number | NA |
| Catalog Number | 28122474001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-24 |