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 2015-10-12 for T4 12017709122 manufactured by Roche Diagnostics.
[28040528]
This event occurred in (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[28040529]
The customer complained of erroneous results for 1 patient tested for thyrotropin (tsh), triiodothyronine (t3), free triiodothyronine (ft3), thyroxine (t4), and free thyroxine (ft4). The 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 tsh erroneous results, medwatch with patient identifier (b)(6) for information on the t3 erroneous results, medwatch with patient identifier (b)(6) for information on the ft3 erroneous results, and medwatch with patient identifier (b)(6) for information on the ft4 erroneous results. On (b)(6) 2015, the physician complained that thyroid results obtained on an e602 analyzer for this patient did not correspond to his clinical condition. On (b)(6) 2015, the patient had a tsh result of 0. 93 uiu/ml, a t3 result of 160. 4 ng/dl, an ft3 result of 17. 98 pg/ml, a t4 result > 24. 86 ug/dl and an ft4 result >7. 77 ng/dl. This sample was diluted 1:2 by using polyethylene-glycol (peg) precipitation and the tsh result was 2. 68 uiu/ml, the t3 result was 185. 22 ng/dl, ft3 result was 3. 62 pg/ml, t4 result was 11. 12 ug/dl and ft4 result was 2. 76 ng/dl. On (b)(6) 2015, a new sample was obtained and tested on the e602 analyzer. The initial tsh result was 0. 92 uiu/ml, the t3 result was 153. 3 ng/dl, the ft3 result was 15. 83 pg/ml, the t4 result was >24. 86 ug/dl and the ft4 result was >7. 77 ng/dl. The sample was repeated on an architect instrument and the tsh result was 2. 6519 uiu/ml, the t3 result was 52. 36 ng/dl, the ft3 result was 1. 38 pg/ml, the t4 result was 8. 9 ug/dl and the ft4 result was 1. 09 ng/dl. On (b)(6) 2015, an additional sample was tested on the e602 analyzer. The tsh result was 1. 000 uiu/ml, the t3 result was 169. 2 ng/dl, the ft3 result was 16. 3 pg/ml, the t4 result was >24. 86 ug/dl and the ft4 result was >7. 77 ng/dl. No adverse event occurred. The e602 analyzer serial number was (b)(4). On (b)(6) 2015, the application specialist visited the site and the internal quality controls were acceptable.
Patient Sequence No: 1, Text Type: D, B5
[28945853]
The expiration date for t4 was provided as 07/2016.
Patient Sequence No: 1, Text Type: N, H10
[30781186]
An additional sample was obtained for this patient on (b)(4) 2015. The patient was tested on the e602 analyzer and the tsh result was 1. 45 uiu/ml, the t3 result was 280. 2 ng/dl, the ft3 result was 15. 3 pg/ml, the t4 result was >24. 86 ug/dl, and the ft4 result was 7. 77 ng/dl.
Patient Sequence No: 1, Text Type: N, H10
[31054574]
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
| Report Number | 1823260-2015-04312 |
| MDR Report Key | 5144144 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-12 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-09-18 |
| Date Added to Maude | 2015-10-12 |
| 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 | 2015-10-12 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 182845 |
| 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 | 2015-10-12 |