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 2015-02-10 for T4 manufactured by Roche Diagnostics.
[5347722]
The customer reported discordant results for thyroid tests. One patient sample was tested for thyrotropin(tsh), thyroxine (t4), free thyroxine (ft4), triiodothyronine (t3), and free triiodothyronine (ft3). The erroneous results were reported outside of the laboratory. This medwatch will cover t4. Refer to the attached data for the patient results. Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results, medwatch with patient identifier (b)(6) for information on the ft4 erroneous results, medwatch with patient identifier (b)(6) for information on the erroneous t3 results and medwatch with patient identifier (b)(6) for the information on the erroneous ft3 results. The sample was initially tested on the e602 analyzer and then repeated on an abbott architect analyzer. Based on the clinical status of the patient, they expected results in the normal range for someone with a normal functioning thyroid. The original sample was then treated with hbt scantibodies tubes and tests were re-run on the e602 analyzer and repeated on the abbott architect analyzer. No adverse events were reported. The ft4 reagent lot number was 180539. The expiration date was requested but not provided. The ft3 reagent lot number was 180230. The expiration date was requested but not provided. The lot numbers and expiration dates for tsh, t3 and t4 were requested but not provided. The cobas e602 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12836330]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[12954629]
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
[16025233]
Lot number was updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-00987 |
| MDR Report Key | 4504120 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-06-11 |
| Date of Event | 2014-12-22 |
| Date Mfgr Received | 2015-01-22 |
| Date Added to Maude | 2015-02-10 |
| 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 | 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 | 2015-02-10 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 177623 |
| 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 | 2015-02-10 |