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 2010-01-29 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1442652]
Customer had a patient sample for d-dimer (lot #614895) that measured 0. 0 ng/ml. A second measurement also had 0. 0 ng/ml result. Customer experienced this same issue with additional patient samples during the previous week but did not provide results for those samples. A second sample from this patient recovered 0. 0 ng/ml. Customer also ran 3 random samples for d-dimer which all recovered 0. 0 ng/ml. The original sample was run using a biomerieux-minividas and the result was 413 ng/ml. Previous d-dimer result for the patient was 400 ng/ml. Lab uses greiner citrate plasma tubes. No adverse affects were reported. The field application specialist visited the lab and after recalibration and qc, everything was ok. .
Patient Sequence No: 1, Text Type: D, B5
[8512713]
It is unknown if initial reporter sent report to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-00580 |
| MDR Report Key | 1589900 |
| Report Source | 01,05,06 |
| Date Received | 2010-01-29 |
| Date of Report | 2010-01-29 |
| Date of Event | 2010-01-12 |
| Date Facility Aware | 2010-01-12 |
| Date Mfgr Received | 2010-01-12 |
| Date Added to Maude | 2010-01-29 |
| 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 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 | KQG |
| Date Received | 2010-01-29 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2010-01-29 |