MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-03 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1674147]
The customer has received questionable results for multiple assays since (b)(6) 2010. The assays involved during this event were bicarbonate liquid (co2), hdl-cholesterol plus 3rd generation (hdl), alkaline phosphatase acc. To ifcc gen. 2 (alk), triglycerides (trig) and ldl- cholesterol plus 2nd generation (ldl). The customer provided results for six patient samples, results for three samples were discrepant. Patient 1, initial co2 result was 0 mmol/l. The sample repeated on the same cobas 6000 c501 module generated a value of 27 mmol/l. Patient 2, initial hdl result was 0 mg/dl. The sample repeated on the same cobas 6000 c501 analyzer generated a value of 60 mg/dl. Patient 3, initial ldl result was 3 mg/dl. The sample repeated on the same cobas 6000 c501 analyzer generated a value of 142 mg/dl. The initial results were not reported outside the laboratory. No patients were affected by the issue. The reagent lot numbers were not provided. The field service representative did not determine a cause, he suspected a fibrin clot or gel was aspirated. He performed sample probe wash cycles and advised the customer how to handle certain instrument alarms. The field service representative ran precision checks (for three assays) to verify analyzer operation.
Patient Sequence No: 1, Text Type: D, B5
[8828499]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07142 |
| MDR Report Key | 1913295 |
| Report Source | 05,06 |
| Date Received | 2010-12-03 |
| Date of Report | 2010-12-03 |
| Date of Event | 2010-11-18 |
| Date Mfgr Received | 2010-11-18 |
| Date Added to Maude | 2010-12-06 |
| 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 | LBS |
| Date Received | 2010-12-03 |
| 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 | 2010-12-03 |