MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-29 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[2701673]
The customer received a questionable phenytoin result on their c501 analyzer. All testing was performed on the same analyzer. The patient's initial phenytoin result was <0. 8 mcg/ml accompanied by a data flag and it was analyzed in the pour off tube it arrived in. The technician reported this result outside the laboratory. The doctor did not believe the result, called the laboratory, and asked they rerun the sample. The first repeat result was 21. 4 mcg/ml. The second repeat result was 21. 2 mcg/ml. The customer considered the repeat results to be correct and 21. 4 mcg/ml was issued as a corrected report. There were no adverse events. The phenytoin reagent lot number was (b)(4) and the expiration date was 03/31/2013. The customer declined a service visit stating the technician involved in this event had failed to follow procedures in other areas. The customer believed this was an isolated incident and they have not had any other issues with the analyzer.
Patient Sequence No: 1, Text Type: D, B5
[10045637]
A definitive root cause could not be determined. There were no adverse events.
Patient Sequence No: 1, Text Type: N, H10
[10058131]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-03399 |
| MDR Report Key | 2634688 |
| Report Source | 05,06 |
| Date Received | 2012-06-29 |
| Date of Report | 2012-07-18 |
| Date of Event | 2012-06-11 |
| Date Mfgr Received | 2012-06-13 |
| Date Added to Maude | 2012-06-29 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2012-06-29 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| 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 | 2012-06-29 |