MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-22 for ELECSYS 2010 RACK 11804014001 manufactured by Roche Diagnostics.
[1462687]
The user stated they ran one patient serum sample for free t4 and received a result of 5. 75 ng/dl which was reported. The doctor questioned the result and the same sample was repeated on (b) (6) 2010 with a result of 0. 964 ng/dl. The user did not know if the patient received any treatment based on the initial result. The free t4 reagent lot number was 15567403. The field service representative could not find a cause. He checked the sr and sipper probe adjustments, checked the liquid level detection voltages, checked and cleaned the gripper. To verify the analyzer operation, he ran performance tests, calibration, qc and precision testing with results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[8440491]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-01146 |
| MDR Report Key | 1611180 |
| Report Source | 05,06 |
| Date Received | 2010-02-22 |
| Date of Report | 2010-02-22 |
| Date of Event | 2010-01-25 |
| Date Mfgr Received | 2010-01-28 |
| Date Added to Maude | 2010-02-22 |
| 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 ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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 | ELECSYS 2010 RACK |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | KLI |
| Date Received | 2010-02-22 |
| Model Number | NA |
| Catalog Number | 11804014001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-02-22 |