MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-13 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[2324188]
The customer received erratic calcium results for three days. The customer issued eight corrected reports, but provided data for one patient with discrepant results reported outside the laboratory. The customer noticed calcium was running "7 something" and repeating "9 something". The patient's initial calcium result was 4. 0 mg/dl and it was reported outside the laboratory. The sample was repeated on a standalone c501. The repeat result was "6 something". The customer deemed the "6 something" result was correct and it was issued as a corrected report. No patients were adversely affected by this event. The calcium reagent lot number was 64585701 and the expiration date was 12/31/2011. The field service representative determined the event was caused by fluidics failure due to poor cell wash and contamination in the analyzer water lines. He adjusted all fluidics dispenses and pressures. He did a complete decontamination of the analyzer. A patient comparison was performed between the c6000 and the standalone c501 with matching results. The customer performed calibration and quality control with all results within range.
Patient Sequence No: 1, Text Type: D, B5
[9458057]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-04834 |
| MDR Report Key | 2245100 |
| Report Source | 05,06 |
| Date Received | 2011-09-13 |
| Date of Report | 2011-09-13 |
| Date of Event | 2011-08-21 |
| Date Mfgr Received | 2011-08-21 |
| Date Added to Maude | 2011-09-13 |
| 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 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 | JFP |
| Date Received | 2011-09-13 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| 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 | 2011-09-13 |