MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-05-07 for COBAS 6000 CORE 04745868001 manufactured by Roche Diagnostics.
[1548926]
The user stated he had two results for phenytoin which had to be corrected. All results are in ug/ml. Sample 1 initial result was 1, repeat result was 16. Sample 2 initial result was 13, repeat result was 18. The initial results for both samples were reported and then corrected later after repeat testing. The patients were not treated or harmed. The lot number of the phenytoin reagent was not provided. The field service representative determined no vacuum was being supplied to the cell wash 1 detergent mixing vessels. The due loss of vacuum was caused by the vacuum supply tubing being unattached to the vacuum vessel. He reattached the vacuum tubing to the vacuum vessel and secured tubing to vessel. To verify the analyzer operation, he performed a cell detergent prime and observed the cell detergent being aspirated; performed wash reaction parts and monitored cell detergent 1 being dispensed properly. The user ran qc and a precision test on phenytoin. All results within the user's specifications and documented guidelines.
Patient Sequence No: 1, Text Type: D, B5
[8466991]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-02769 |
| MDR Report Key | 1676698 |
| Report Source | 05,06 |
| Date Received | 2010-05-07 |
| Date of Report | 2010-05-07 |
| Date of Event | 2010-04-25 |
| Date Mfgr Received | 2010-04-25 |
| Date Added to Maude | 2010-05-07 |
| 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 ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2010-05-07 |
| Model Number | NA |
| Catalog Number | 04745868001 |
| 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 | 2010-05-07 |