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 2017-02-07 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.
[66769111]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66769112]
The customer initially questioned results for 1 patient tested for elecsys ft4 ii assay (ft4ii) on a cobas 8000 e 602 module. The patient? S thyroid function was examined on (b)(6) 2016 and (b)(6) 2017. The thyroid results from the e602 module at the customer site for these dates were very similar. Most of the thyroid tests showed positive results, however the patient had no significant thyroid discomfort. The patient went to a different hospital on (b)(6) 2016 where a siemens instrument was used and her thyroid results were normal. The customer took the patient sample from (b)(6) 2017 and repeated it on a beckman instrument and another e602 instrument at another site and erroneous ft4 ii, thyrotropin (tsh), triiodothyronine (t3), thyroxine (t4), ft3? Free triiodothyronine (ft3) and antibodies to thyroid peroxidase (anti-tpo) results were identified. This medwatch will cover t4. Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous results, 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 anti-tpo erroneous results. Refer to attached data for patient results. No adverse event occurred. The e602 module serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[68493572]
The customer stated instrument maintenance and sample processing is according to specifications. Quality controls are run daily and have been acceptable. A specific root cause could not be identified. Additional information was requested for investigation but was not provided. The patient sample cannot be provided for investigation. Based on the information available for investigation, a general reagent issue can most likely be excluded. The differences between the roche results and the results from other manufacturers may be due to assay interfering factors. These interfering factors may affect the thyroid assays from roche and other manufacturers differently. However, since the patient sample cannot be provided, this cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00237 |
| MDR Report Key | 6308606 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-01-06 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-02-07 |
| 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 | 2017-02-07 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |