MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-06-16 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1621120]
The user stated they failed a proficiency survey for c-reactive protein and performed a patient comparison as part of troubleshooting the issue. Of the data provided, the result for one neonatal sample was discrepant. The result from the c501 was 4. 28 mg/l and the result with another c- reactive protein application on another c501 analyzer (b) (4) was 0. 33 mg/dl (3. 3 mg/l). The user could not verify if the result of 4. 28 mg/l was reported. The user refused to provide further patient information. The reagent lot number of the c-reactive protein reagent was 62203601. The user refused a service visit for this issue.
Patient Sequence No: 1, Text Type: D, B5
[8625790]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[17530529]
It was reported to boston scientific corporation that a flexima biliary stent system was used during a drainage procedure in the bile duct of a patient (the event date, patient age, sex, and weight are unknown). During the procedure, the physician felt strong resistance and the guide catheter broke as the guide catheter was retracted for stent deployment. The procedure was successfully completed with another flexima biliary stent system no reported patient complications. The patient was reported to be in good condition after the procedure.
Patient Sequence No: 1, Text Type: D, B5
[17596850]
The investigation could not determine a clear root cause as adequate data such as diagnosis, medication, history, sample material and reaction kinetics were not provided. It was unknown if any diagnosis and/or treatment was made to the patient based on the false positive result. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-03566 |
| MDR Report Key | 1724570 |
| Report Source | * |
| Date Received | 2010-06-16 |
| Date of Report | 2010-11-11 |
| Date of Event | 2010-06-02 |
| Date Mfgr Received | 2010-06-03 |
| Date Added to Maude | 2010-11-11 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| 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 |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2010-06-16 |
| Catalog Number | 05036453001 |
| 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 INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-16 |