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 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1904908]
The user discovered questionable ethanol generation 2 (alcohol) results for four patient samples when a doctor questioned the result for one patient sample. All repeat testing was performed on another cobas c501 analyzer on (b)(6) 2010. All results are in mg/dl. Patient sample 1 initial result was 39 and was reported outside the laboratory. The result was questioned by the emergency room doctor and the sample was repeated with a result of 541 with a data flag and 561. Patient sample 2 initial result on (b)(6) 2010 was 69 and the repeat result was 1 which was reported outside the laboratory as < 10. Patient sample 3 initial result on (b)(6) 2010 was 17 and the repeat result was -2 with a data flag which was reported outside the laboratory as < 10. Patient sample 4 initial result was 6 with a data flag and the repeat result was 0 with a data flag twice which was reported outside the laboratory as < 10. The initial results had been reported outside the laboratory for all four patient samples. No adverse events were alleged regarding the event. The alcohol reagent lot number was 63260401. The user stated they had received an analyzer alarm earlier and after the erroneous results, they found the alcohol reagent cassette was displayed on the reagent screen but no reagent cassette was actually on the reagent wheel. The field service representative determined the operator had removed the alcohol reagent pack but didn't verify the reagent map to determine if the cassette was successfully removed. The instrument gave an alarm due to there being no cassette actually present in the position. He noted the technical support specialist had assisted while the operator replaced the cassette and successfully updated the reagent cassette load list prior to his arrival onsite. He verified the instrument was operational after rebooting of system, verified all the gripper adjustments which passed, removed and reloaded several reagent cassettes with no errors and performed mechanism checks which passed. To verify the analyzer operation, the user ran calibration and quality control with all results passing. The field application specialist determined the reagent cassette failed to register that it was off loaded and the reagent status remained on board after the request for removal. She reviewed with the customer how to monitor manually requested off loaded cassettes against the software display.
Patient Sequence No: 1, Text Type: D, B5
[8931120]
.
Patient Sequence No: 1, Text Type: N, H10
[16092652]
Investigation of the event determined the issue was caused by a gripper failure. The user ignored three methods of instruction on how to handle the gripper failure. The online help instructions provided by the software and instructions for this issue out of the service bulletin were not followed by the customer. In addition, the customer did not notify the service representative when the alarm reoccurred. The issue was resolved by the service visit. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-00341 |
| MDR Report Key | 1968309 |
| Report Source | 05,06 |
| Date Received | 2011-01-24 |
| Date of Report | 2011-05-13 |
| Date of Event | 2010-12-27 |
| Date Mfgr Received | 2010-12-28 |
| Date Added to Maude | 2011-04-07 |
| 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 |
| 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 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DIC |
| Date Received | 2011-01-24 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| 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 |