MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-08 for COBAS 311 04826876001 manufactured by Roche Diagnostics.
[1733195]
The user received questionable albumin results for two patient samples. Of the provided data, the result for one sample was discrepant. All results are in g/dl. The initial result was 4. 0 and the repeat result was 2. 7. The user stated the high result was noticed because the globulin calculation generated a low result of 0. 4. No unit of measure was provided. This was flagged in the computer system prompting the repeat testing. The initial result for albumin was released and the patient was not harmed based on the initial result. The albumin reagent lot number was 62171501. The field service representative could not duplicate the issue. He checked the probe alignment and verified the analyzer operation by having the user run a precision check on a patient sample and quality control material.
Patient Sequence No: 1, Text Type: D, B5
[8934623]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-00677 |
| MDR Report Key | 1980994 |
| Report Source | 05,06 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-02-08 |
| Date of Event | 2011-01-18 |
| Date Mfgr Received | 2011-01-18 |
| Date Added to Maude | 2011-02-08 |
| 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 RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| 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 311 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIX |
| Date Received | 2011-02-08 |
| Model Number | NA |
| Catalog Number | 04826876001 |
| 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 | 2011-02-08 |