MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-17 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1957567]
The customer received questionable ldl-cholesterol plus 2nd generation (ldl) results for one patient sample. The initial ldl result was 10 mg/dl and was reported outside the laboratory. The patient's other lipid results were high (triglyceride= 1799 mg/dl and cholesterol= 244 mg/dl), therefore, the customer sent the sample to be retested at an outside laboratory. The sample was repeated on an unspecified beckman analyzer and recovered 178 mg/dl. The customer considered the rerun value of 178 mg/dl to be correct and a corrected report was issued for the patient. The patient was not adversely affected. The ldl reagent lot number was 61704801. The customer declined a field service dispatch to investigate the issue because she believed the issue was related to the sample and not the analyzer.
Patient Sequence No: 1, Text Type: D, B5
[9221354]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-01470 |
| MDR Report Key | 2022545 |
| Report Source | 05,06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-03-17 |
| Date of Event | 2011-02-24 |
| Date Mfgr Received | 2011-03-01 |
| Date Added to Maude | 2011-03-17 |
| 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 RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| 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 | LBR |
| Date Received | 2011-03-17 |
| 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 | 2011-03-17 |