MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07027397190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of erroneous results for 1 patient sample tested for elecsys ft4 ii (ft4 ii), elecsys tsh (tsh), elecsys ft3 iii (ft3 iii), elecsys anti-tpo (anti-tpo) and elecsys anti-tshr immunoassay (anti-tshr) on a cobas e 801 module compared to the architect method and the (b)(4) method.The erroneous results were reported outside of the laboratory where the physician requested an investigation as the patient may be taking biotin.This medwatch will cover ft4 ii.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 ft3 iii erroneous results, medwatch with patient identifier (b)(6) for information on the anti-tpo erroneous results and medwatch with patient identifier (b)(6) for information on the anti-tshr erroneous results.There was no allegation that an adverse event occurred.The (b)(4) serial number was not provided.A specific root cause was not identified.Additional information was requested for investigation but was not provided.The discrepant results may be caused by a biological component in the sample that interacts differently with the roche assays and the assays from other manufacturers.Since the patient may be taking biotin, the discrepant results could also be caused by the presence of higher doses of biotin in the patient sample, however since there was not enough sample to complete the investigation, neither of these possibilities could be confirmed.Based on the information available, a general reagent issue can most likely be excluded.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7219702
• MDR Text Key: 98432831
• Report Number: 1823260-2018-00243
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 57