MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-20 for TOTAL PROTEIN GEN.2 03183734190 manufactured by Roche Diagnostics.
[18617996]
The user received a questionable total protein result for one patient sample from the cobas c501 analyzer serial number (b)(4). The initial result was 0. 3 g/dl and was reported outside the laboratory. When the user received another sample from the same patient and tested it, the system issued an alert because the current result did not match the result from the previous sample. The user pulled the original sample and repeated testing on (b)(6) 2011 with a result of 8. 0 g/dl. Per laboratory protocol, the user filed a corrected report. The patient was not adversely affected. Upon evaluation of the analyzer, the field service representative determined there was a fluidic failure due to an unknown material found floating in the original sample tube. He taught the user the importance of pre-analytic sample handling and replaced the sample probe as a preventive measure. To verify the analyzer operation, the user ran calibration, quality control, and precision testing with results within their specifications.
Patient Sequence No: 1, Text Type: D, B5
[18744647]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03338 |
| MDR Report Key | 2133637 |
| Report Source | 05,06 |
| Date Received | 2011-06-20 |
| Date of Report | 2011-06-20 |
| Date of Event | 2011-06-05 |
| Date Mfgr Received | 2011-06-06 |
| Date Added to Maude | 2011-06-20 |
| 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 RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL PROTEIN GEN.2 |
| Generic Name | BIURET (COLORIMETRIC), TOTAL PROTEIN |
| Product Code | CEK |
| Date Received | 2011-06-20 |
| Model Number | NA |
| Catalog Number | 03183734190 |
| Lot Number | 63701701 |
| ID Number | NA |
| Device Expiration Date | 2012-03-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2011-06-20 |