MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-05-10 for ELECSYS T4 ASSAY 07027885190 manufactured by Roche Diagnostics.
[108362591]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108362592]
The customer questioned results for 1 patient tested for elecsys t4 (t4) and elecsys (tsh) on a cobas e801 module. The patient had a thyroid gland resection in 2009 due to struma multinodosa. The results from a thyroid scintigraphy confirm a small amount of residual thyroid tissue. The patient has a family history of thyroid hormone resistance with autosomal dominant inheritance. The patient is treated intravenously with 2mg of l-thyroxine per day. The patient is clinically considered to have hypothyroidism. The customer is concerned that the tsh results are always high and the t4 results are low. This medwatch will cover t4. Refer to medwatch with patient identifier (b)(6) for information on the tsh results. Refer to attached data for the patient results. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). The customer stated calibration and qc results were within the acceptable ranges with no issues. The customer is wondering if there is an interference in the patient sample affecting the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01439 |
| MDR Report Key | 7502569 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-10 |
| 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 |
| 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 | ELECSYS T4 ASSAY |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2018-05-10 |
| Model Number | T4 |
| Catalog Number | 07027885190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-10 |