MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR IMMUNOASSAY; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/17/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for three samples from the same patient tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and the elecsys anti-tshr immunoassay (trab) on a cobas 8000 e 602 module (e602).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.This medwatch will apply to the trab assay.Patient identifiers for information pertaining to the other assays: tsh = (b)(6), ft3 = (b)(6), ft4 = (b)(6).The three samples with erroneous results were tested on (b)(6) 2017.The customer stated that the elecsys thyroid test results for two of the three samples tested on (b)(6) 2017 and (b)(6) 2017 did not match the patient's clinical symptoms.The samples tested on (b)(6) 2017 and (b)(6) 2017 were also tested on an architect analyzer.No abnormalities were seen with the architect measurements and these were different from the elecsys values.The patient takes 2 doses 10 mg of biotin medication every day, once in the morning and once in the evening.For the sample tested on (b)(6) 2017, the patient only took biotin medication on the evening prior to sample collection.The customer believes that the patient's biotin medication is interfering with the elecsys thyroid assays.The customer stated that since biotin medication was taken by the patient only on the night before, the elecsys thyroid test measurements performed on the (b)(6) 2017 sample matched the patient's clinical findings.No adverse events were alleged to have occurred with the patient.The e602 analyzer serial number was (b)(4).

Manufacturer Narrative

A high biotin concentration (256 ng/ml) was detected in the sample dated (b)(6) 2017.The concentration was far above the biotin concentration thresholds mentioned in product labeling for the tsh, ft3, anti-tshr, and ft4 assays.The high biotin concentration most likely caused the high ft3 and ft4 values and the low tsh value.The high biotin concentration may have likely caused the incorrect anti-tshr result.A high biotin concentration (364 ng/ml) was also detected in the sample dated (b)(6) 2017.The concentration was far above the biotin concentration thresholds mentioned in product labeling for the tsh, ft3, anti-tshr, and ft4 assays.The high biotin concentration most likely caused the high ft3 and ft4 values and the low tsh value compared to values generated with the abbott architect analyzer.The high biotin concentration may have likely caused the incorrect anti-tshr result.The biotin concentration (59.1 ng/ml) of the (b)(6) 2017 sample was found to be near the biotin concentration thresholds mentioned in product labeling for the tsh, ft3, anti-tshr, and ft4 assays.Product labeling for the anti-tshr assay indicates that there is no biotin interference up to 10 ng/ml.Samples should not be taken from patients receiving therapy with high biotin doses (e.G.Greater than 5 mg/day) until at least 8 hours following the last biotin administration.

Manufacturer Narrative

Three samples from the patient dated (b)(6) 2017, (b)(6) 2017, and (b)(6) 2017 were provided for investigation.The samples were checked for potential interfering factors.An interfering factor against a component of the reagent could not be excluded.Investigations are ongoing.

• Brand Name: ELECSYS ANTI-TSHR IMMUNOASSAY
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 6896644
• MDR Text Key: 89526913
• Report Number: 1823260-2017-02110
• Device Sequence Number: 0
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• 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: 56 YR