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 2018-02-15 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.
[100452506]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100452507]
The customer complained about the results for 1 patient tested on multiple assays on the elecsys e170 modular analytics immunoassay analyzer. The patient was tested for elecsys ft4 ii assay (ft4 ii), elecsys tsh assay (tsh), elecsys t4 assay (t4), elecsys t-uptake assay (t-uptake), elecsys fsh assay (fsh), elecsys t3 (t3), elecsys ft3 iii (ft3 iii), elecsys estradiol iii assay (estradiol iii), elecsys progesterone iii (progesterone iii), elecsys pth (1-84) pth 1-84 and elecsys ferritin (ferritin). The pth 1-84 assay is not released for distribution in the united states nor is it similar to a device released for distribution in the united states. The results were reported outside of the laboratory where the physician did not believe the results. The patient is being treated with 100 mg of biotin per day for multiple sclerosis. The customer is wondering if the biotin treatment is interfering with the patient's test results. Product labeling states "samples should not be taken from patients receiving therapy with high biotin doses (i. E. > 5 mg/day) until at least 8 hours following the last biotin administration. " the customer repeated the patient sample after treating it with a streptavidin coated bead treatment. The procedure used by the customer is unknown. The ft4 ii, tsh, t4, t-uptake, t3, ft3 iii, estradiol iii and ferritin results were discrepant when compared to the results initially released from the laboratory. Refer to medwatches with the following patient identifiers for the affected assays: (b)(6). Refer to the attached data for the patient results. There was no allegation that an adverse event occurred. The e170 analyzer serial number was (b)(4). The discrepant results generated during the customer's experiment were consistent with patients being treated with high biotin dosages. As no sample material was left, an investigation of the sample material could not be completed. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00462 |
| MDR Report Key | 7273740 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-15 |
| Date of Event | 2018-01-29 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-02-15 |
| 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 | ELECSYS T4 ASSAY |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2018-02-15 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2018-02-15 |