MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-27 for T-UPTAKE 11731394122 manufactured by Roche Diagnostics.
[15409231]
The customer received questionable t-uptake results when tested on an elecsys 2010 rack analyzer, serial number (b)(4). The issue began on (b)(6) 2011 and involved nine patients. Results for four of the patients were discrepant. According to the customer, (b)(6) 2011 is the first day the issue was observed, however, she did not know the specific dates of testing for the original results. All repeat testing was performed (b)(6) 2011 on the same elecsys 2010 rack analyzer. Patient 1, original result was 43 tbi. The repeat result was 28. 44 tbi. Patient 2, original result was 44 tbi. The repeat result was 28. 69 tbi. Patient 3, original result was 51 tbi. The repeat result was 33. 13 tbi. Patient 4, original result was 43 tbi. The repeat result was 26. 30 tbi. According to the customer, some of the results were reported outside the laboratory, but she did not know which ones. The patients were not adversely affected by the event. The field service representative determined the age of the measuring cell was the cause and he replaced the measuring cell. The field service representative ran performance tests which were acceptable. The customer performed calibration and quality control which were successful.
Patient Sequence No: 1, Text Type: D, B5
[15719246]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02816 |
| MDR Report Key | 2104897 |
| Report Source | 05,06 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-27 |
| Date of Event | 2011-05-07 |
| Date Mfgr Received | 2011-05-12 |
| Date Added to Maude | 2011-05-27 |
| 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 | T-UPTAKE |
| Generic Name | RADIOASSAY, TRIIODOTHYRONINE UPTAKE |
| Product Code | KHQ |
| Date Received | 2011-05-27 |
| Model Number | NA |
| Catalog Number | 11731394122 |
| Lot Number | 16169901 |
| ID Number | NA |
| Device Expiration Date | 2012-05-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-05-27 |