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 2015-08-24 for T4 manufactured by Roche Diagnostics.
[24306592]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24662619]
The sample was submitted for investigation. Investigation confirmed the presence of a streptavidin interfering factor. This specific interference is addressed in product labeling.
Patient Sequence No: 1, Text Type: N, H10
[25887898]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[25887899]
The customer complained of erroneous results for 1 patient sample tested for free thyroxine (ft4). Of the data provided, erroneous thyrotropin (tsh), free triiodothyronine (ft3), thyroxine (t4), and triiodothyronine (t3) were also identified. The erroneous results were reported outside of the laboratory. This medwatch will cover t4. Refer to medwatch with (b)(6) for information on the ft4 erroneous results, medwatch with (b)(6) for information on the tsh erroneous results, medwatch with (b)(6) for information on the ft3 erroneous results, and medwatch with (b)(6) for information on the t3 erroneous results. Based on the ft4 results, it was suspected that the patient had hyperthyroidism and was prescribed anti-thyroid medications of propylthiouracil and thiamazole for 2 consecutive days. No adverse event occurred due to this treatment. The e601 analyzer used at the customer site was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-04012 |
| MDR Report Key | 5024940 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-24 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-05-20 |
| Date Mfgr Received | 2015-07-31 |
| Date Added to Maude | 2015-08-24 |
| 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 | T4 |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2015-08-24 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 0182845 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-08-24 |