MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-12-03 for T4 manufactured by Roche Diagnostics.
[32599585]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[32599586]
The customer questioned results from 2 samples from the same patient tested for thyrotropin (tsh), free thyroxine (ft4) and ft3 -free triiodothyronine (ft3 iii). The customer provided the patient samples for investigation. Of the samples provided, erroneous ft3 iii results were identified for 1 sample between the customer's e602 analyzer, a centaur analyzer, and a modular e analyzer used at the investigation site. Based on the data provided, erroneous t4 results were identified from the same sample between the modular e analyzer used at the investigation site and the centaur. It is not known if erroneous results were reported outside of the laboratory. This medwatch will cover t4. Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results. See the attachment to the medwatch for patient results. No adverse event was reported. The modular e analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[35781401]
The patient sample was submitted for investigation. The customer's results were reproduced. The t4 results were within the reference range. Interference testing was performed. No interferences were identified. The values of a given parameter generated by assays from different suppliers may be different due to the overall setup of the assay, the antibodies used and differences in reference materials/methods and the standardization method used. Further clarification of the differences between the roche and siemens centaur analyzers is not possible with the current methods available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04675 |
| MDR Report Key | 5263863 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-03 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2015-11-18 |
| Date Added to Maude | 2015-12-03 |
| 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 EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T4 |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2015-12-03 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 182845 |
| ID Number | NA |
| Device Expiration Date | 2016-05-31 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2015-12-03 |