MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-15 for T4 12017709122 manufactured by Roche Diagnostics.
[38228591]
Patient Sequence No: 1, Text Type: N, H10
[38228592]
The customer reported that they received erroneous results for one patient sample tested for thyrotropin (tsh), triiodothyronine (t3), and thyroxine (t4). The customer states that the patient has had questionably high t3 and t4 test results since the beginning of (b)(6) 2013. This medwatch will cover t4. Please refer to the medwatch with patient identifier (b)(6) for information related to t3 and refer to the medwatch with patient identifier (b)(6) for information related to tsh. A sample from (b)(6) 2015 was initially tested at the customer site, "mgh", on an e601 analyzer. The results from the e601 analyzer were reported to the physician, who did not believe the results. The results did not match the patient's clinical presentation, so the sample was sent to a reference laboratory for additional testing. The sample was then tested at the reference laboratory, "srh", on an abbott architect analyzer. The results from the abbott architect analyzer were believed to be correct. Refer to the attachment for the sample results. The patient was not adversely affected. The e601 analyzer serial number was (b)(4). The customer declined a service visit and believed the issue to be patient specific. The customer alleged the erroneous results were due to interference by exogenous biotin taken by the patient. A specific root cause could not be determined based on the provided information. The patient sample was requested for investigations, but could not be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-00150 |
| MDR Report Key | 5436491 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-15 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-04-21 |
| Date Mfgr Received | 2016-01-27 |
| Date Added to Maude | 2016-02-15 |
| 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 | 2016-02-15 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 17762302 |
| ID Number | NA |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-02-15 |