MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-19 for COBAS INTEGRA 400 PLUS 03245233692 manufactured by Roche Diagnostics.
[3140653]
The customer received questionable phenytoin results for two patient samples. Patient sample 1 initial result was >40 ug/ml. The sample was diluted 1:2 offline and repeated with results of 32. 38 ug/ml and 30. 81 ug/ml. The undiluted sample was repeated and with a result of 32. 15 ug/ml. On (b)(6) 2013, patient sample 2 was from a (b)(6) male. The initial result was >40 ug/ml. The sample was diluted 1:2 offline and repeated with results of 10. 8 ug/ml and 9. 25 ug/ml. The undiluted sample was repeated and with a result of 9. 27 ug/ml. The customer assumed the lower values to be correct as neither patient had a history of high phenytoin results. The erroneous results were not reported outside the laboratory. The patients were not adversely affected. The phenytoin reagent lot number was 67041501 with an expiration date of 01/31/2014. The field service representative problem determined there was a problem with the rotor belt. He replaced the rotor belt, performed work station accuracy check and adjust rotor initialization position. To verify the analyzer operation, he ran performance testing, photometer precision and a standard deviation test with passing results.
Patient Sequence No: 1, Text Type: D, B5
[10461005]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-00981 |
| MDR Report Key | 2967679 |
| Report Source | 05,06 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-02-19 |
| Date of Event | 2013-01-25 |
| Date Mfgr Received | 2013-01-29 |
| Date Added to Maude | 2013-02-19 |
| 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 | 2013-02-19 |
| 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 | 2013-02-19 |