MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-16 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[2352030]
Then user received questionable high phosphorus results for patient samples that were discovered when a doctor called questioning the results. The samples were repeated on cobas c501 analyzer serial number (b)(4) and those results were considered correct. Of the data provided, the results for nine patient samples were discrepant. All results are in mg/dl. Patient sample 1 initial result was 5. 6 and the repeat result was 3. 3. Patient sample 2 initial result was 5. 5 and the repeat result was 3. 6. Patient sample 3 initial result was 3. 1 and the repeat result was 2. 1. Patient sample 4 initial result was 3. 5 and the repeat result was 2. 5. Patient sample 5 initial result was 6. 4 and the repeat result was 3. Patient sample 6 initial result was 8. 6 and the repeat result was 3. 6. Patient sample 7 initial result was 6. 5 and the repeat result was 4. 8. Patient sample 8 initial result was 6. 1 and the repeat result was 2. 4. Patient sample 9 initial result was 1. 7 and the repeat result was 1. 3. The initial results were reported outside the laboratory. No patients were adversely affected. The phosphorus reagent lot number was 64166101 with an expiration date of 07/31/2012. The field service representative determined there was a fluidics failure. He replaced valve blocks, decontaminated the system and rinse tubings, adjusted all rinse volumes and aligned syringe barrels. To verify the analyzer operation, he ran calibration, quality control and precision testing.
Patient Sequence No: 1, Text Type: D, B5
[9486218]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-06211 |
| MDR Report Key | 2338315 |
| Report Source | 05,06 |
| Date Received | 2011-11-16 |
| Date of Report | 2011-11-16 |
| Date of Event | 2011-10-20 |
| Date Mfgr Received | 2011-10-31 |
| Date Added to Maude | 2011-11-16 |
| 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 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEO |
| Date Received | 2011-11-16 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-11-16 |