MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-05 for COBAS INTEGRA 400 PLUS 03245233692 manufactured by Roche Diagnostics.
[3700056]
The customer received questionable phenytoin results for two patient samples beginning on (b)(6) 2013. Data was only provided for one patient sample which was tested on (b)(6) 2013. The initial result was >40 ug/ml. The repeat result was 7. 2 ug/ml twice. The customer stated the results were accompanied by data flags. The erroneous result was not reported outside the laboratory. The repeat result was believed to be correct. The patient was not adversely affected. The phenytoin reagent lot number was 67041501 with an expiration date of 01/31/2014. The field service representative determined the alignments were off and found the workstation accuracy check failed. He made adjustments and performed a workstation in/out adjustment. To verify the analyzer operation he ran a check test and a fluorescence polarization (fp) test with results within acceptable limits. He checked the rotor initialization position and the workstation accuracy.
Patient Sequence No: 1, Text Type: D, B5
[11134816]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05462 |
| MDR Report Key | 3326728 |
| Report Source | 05,06 |
| Date Received | 2013-09-05 |
| Date of Report | 2013-09-05 |
| Date of Event | 2013-08-22 |
| Date Mfgr Received | 2013-08-22 |
| Date Added to Maude | 2013-09-05 |
| 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 | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| 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 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2013-09-05 |
| Model Number | NA |
| Catalog Number | 03245233692 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| 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 | 2013-09-05 |