MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-05-28 for T4 manufactured by Roche Diagnostics.
[13477884]
The 3 patient samples were submitted for investigation. The 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
[13491044]
Clarification was received that the "s-trak" results are results for antibodies to tsh receptor (anti-tshr). The results for each patient were obtained from the same sample. Clarification was received that the erroneous results were reported outside of the laboratory where the physicians did not agree with the results. Clarification was received that none of the patients were adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[19985598]
The customer complained of erroneous high "s-trak" results for 3 patient samples when compared between the cobas system and a brahms kryptor compact system. The "s-trak" results are believed to be results for antibodies to tsh receptor (anti-tshr). The values were normal for all 3 patients on the brahms kryptor compact system which matched the clinical picture for each patient. The customer noted that, for these 3 patients, other thyroid tests also ran higher on the cobas system when compared to other analyzers. Based on the data provided erroneous thyrotropin (tsh), free thyroxine (ft4), thyroxine (t4), free triiodothyronine (ft3), and triiodothyronine (t3) were identified. It is not known if erroneous results were reported outside of the laboratory. This information was requested. The date of event for each patient is not known. Please see the attachment to the medwatch for test results and patient demographics. This medwatch will cover t4. Refer to medwatch with patient identifier (b)(6) for information on the anti-tshr erroneous results. Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results. Refer to medwatch with patient identifier (b)(6) for information on the ft4 erroneous results. Refer to medwatch with patient identifier (b)(6) for information on the ft3 erroneous results. Refer to medwatch with patient identifier (b)(6) for information on the t3 erroneous results. No adverse events reported. The cobas e602 analyzer serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
[20431936]
This event occurred in (b)(6). Patient was born in 1950. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03536 |
| MDR Report Key | 4802578 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-28 |
| Date of Report | 2015-06-23 |
| Date of Event | 2015-05-03 |
| Date Mfgr Received | 2015-05-03 |
| Date Added to Maude | 2015-05-28 |
| 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 | 0 |
| 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 | 2015-05-28 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2015-05-28 |