MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-04 for COBAS 6000 CORE 05036453001 manufactured by Roche Diagnostics.
[2254972]
The user complained of high recovery for theophylline. He decided to send samples out to be tested on an abbott axsym analyzer and found the patient samples recovered on average 43% higher on the cobas c501 analyzer. Data was provided for four patient samples of which, the results for three were discrepant. All results are in umol/l. Patient sample 1 result from the cobas was 17 and the result form the axsym was 11. On (b)(6) 2011, patient sample 2 result from the cobas was 129 and the result form the axsym was 88. On (b)(6) 2011, patient sample 3 result from the cobas was 49 and the result form the axsym was 29. No information was provided to determine if the erroneous results were reported outside the laboratory or if any patients were adversely affected. The theophylline reagent lot number was 640209. The user stated he will continue to monitor the situation and report the result from the axsym analyzer for the time being.
Patient Sequence No: 1, Text Type: D, B5
[9434118]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9651057]
A reagent quality issue was previously identified and is currently under investigation. A work-around has been provided for and communicated to customers until a new lot of the reagent is available. This reagent quality issue may have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05199 |
| MDR Report Key | 2273706 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-04 |
| Date of Report | 2012-03-02 |
| Date of Event | 2011-09-08 |
| Date Mfgr Received | 2011-09-13 |
| Date Added to Maude | 2011-10-04 |
| 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 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KLS |
| Date Received | 2011-10-04 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| 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 | 2011-10-04 |