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 2019-02-11 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR 04388780190 manufactured by Roche Diagnostics.
[135715531]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[135715532]
The customer complained of a possible biotin interference for 1 patient tested for elecsys tsh assay (tsh), elecsys ft4 ii (ft4 ii), elecsys t3 (t3) and elecsys anti-tshr immunoassay (anti-tshr) on a cobas 8000 e 602 module. This medwatch will cover anti-tshr. Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the ft4 ii results and medwatch with patient identifier (b)(6) for information on the t3 results. The patient has multiple sclerosis and has been taking higher doses of biotin (3 x 100 mg per day) for the past 6 months. The patient takes biotin each day at 8:00 a. M. , 3:00 p. M. And 11:00 p. M. The patient sample in question was drawn at 8:30 a. M. On (b)(6) 2018. The patient didn't remember if he had taken biotin at 8:00 a. M. Or not. The customer performed a procedure on the patient sample to remove the biotin from the sample and repeated the sample. Refer to attached data for the patient results. No erroneous results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The e602 module serial number was (b)(4). The patient sample could not be provided for investigation. Product labeling states that the anti-tshr assay is unaffected by biotin levels up to 10 ng/ml 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. Since the sample could not be provided, the biotin interference could not be investigated. From the data provided, a general reagent issue can be excluded. The investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00542 |
| MDR Report Key | 8325420 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-11 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR |
| Generic Name | ANTI-TSHR IMMUNOASSAY |
| Product Code | JZO |
| Date Received | 2019-02-11 |
| Model Number | NA |
| Catalog Number | 04388780190 |
| Lot Number | ASKU |
| 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 | 2019-02-11 |