MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-17 for COBAS 6000 C501 MODULE 04745914001 manufactured by Roche Diagnostics.
[2355721]
The user received questionable hdl-cholesterol plus 3rd generation (hdl) results for two patient sample that were discovered when the physician questioned the results. Patient sample 1 initial result was 98 mg/dl and the repeat result on (b)(6) 2011 was 58 mg/dl. On (b)(6) 2011, patient sample 2 initial result was 73 mg/dl and the repeat result on (b)(6) 2011 was 37 mg/dl. The reported result was corrected for both samples with the repeat value. The patients were not adversely affected. The hdl reagent lot number was 64462901 with an expiration date of 01/31/2013. The field service representative determined there was a fluidics failure of the rinse mechanism. He performed corrective maintenance and verified the analyzer operation by running precision testing with results within specification, calibration and quality control.
Patient Sequence No: 1, Text Type: D, B5
[9484401]
It was unknown if the initial reporter sent report to the fda. There was a fluidics failure of the rinse mechanism.
Patient Sequence No: 1, Text Type: N, H10
[9495174]
Additional information was provided from the field service representative stating the fluidic failure of the rinse mechanism was due to the rinse fluid distribution one-way valve being clogged. The failure was being visually seen at the rinse mechanism but was actually caused by the rinse fluid distribution one-way valve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-06237 |
| MDR Report Key | 2340806 |
| Report Source | 05,06 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-12-08 |
| Date of Event | 2011-09-19 |
| Date Mfgr Received | 2011-11-07 |
| Date Added to Maude | 2011-11-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LBS |
| Date Received | 2011-11-17 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-11-17 |