MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter stated they received discrepant results for two samples from the same patient tested with thyroid assays on the cobas 6000 e 601 module and a cobas 8000 e 602 module used for investigation.One sample labeled "sample 2" had discrepant values for elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay when tested on both systems.The other sample labeled "sample 1" had discrepant values for tsh and the elecsys tsh assay version 2 (tshv2) when tested on the e 602 system.The values measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the tshv2 assay, refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay, and refer to the medwatch with patient identifier (b)(4) for information related to the ft4 assay.Refer to the attachment for all patient data.Values highlighted in yellow are erroneous.The sample labeled "sample 2" was measured at the customer site on (b)(6)2019.The sample labeled as "sample 1" was collected and tested on a different date at a different time, but this date/time is unknown.The samples were provided for investigation and tested on the e 602 analyzer.Tsh, ft3, and ft4 were tested on the e 602 for sample 2 on (b)(6) 2020.All testing for sample 1 was performed on the e 602 analyzer on (b)(6) 2020.For investigations, the sample was also tested with tsh on the e 602 analyzer before and after treatment with a heterophilic antibody blocking tube (hbt).The serial number of the customer's e 601 analyzer is (b)(4).The serial number of the e 602 analyzer used for investigation is (b)(4).Tsh reagent lot number 429091, with an expiration date of april 2020 was used on this analyzer.

Manufacturer Narrative

Upon further investigation of the patient samples, the customer's results could be duplicated.It was determined there were no interfering factors in the sample.The biotin concentrations in both samples were measured and concentrations of 193 ng/ml and 198 ng/ml were measured.The measured biotin concentration in both samples is above the threshold concentration of the tsh version 1 assay (of 25 ng/ml) and below the threshold concentration of the tsh version 2 assay (of 1200 ng/ml), as specified in the method sheets of both assay versions.This explains the different tsh values of both tsh assay versions; the value of the tsh version 2 assay is considered as correct.

Manufacturer Narrative

The patient had the following relevant test data: on (b)(6) 2017, the patient had a tsh result of 1.890 ¿iu/ml, a ft4 result of 1.46 ng/dl, and a ft3 result of 3.30 pg/ml.On (b)(6) 2017, the patient had a tsh result of 1.634 ¿iu/ml, a ft4 result of 1.51 ng/dl, and a ft3 result of 3.47 pg/ml.On (b)(6) 2018, the patient had a tsh result of 0.879 ¿iu/ml, a ft4 result of 1.24 ng/dl, and a ft3 result of 2.29 pg/ml.On (b)(6) 2018, the patient had a tsh result of 1.267 ¿iu/ml, a ft4 result of 1.32 ng/dl, and a ft3 result of 2.83 pg/ml.On (b)(6) 2018, the patient had a tsh result of 0.126 ¿iu/ml, a ft4 result of 2.81 ng/dl, and a ft3 result of 4.06 pg/ml.On (b)(6) 2019, the patient had a tsh result of 0.118 ¿iu/ml, a ft4 result of 2.00 ng/dl, and a ft3 result of 4.11 pg/ml.On (b)(6) 2019, the patient had a tsh result of 0.094 ¿iu/ml, a ft4 result of 1.77 ng/dl, and a ft3 result of 3.40 pg/ml.On (b)(6) 2020, the patient had a tsh result of 0.117 ¿iu/ml, a ft4 result of 1.82 ng/dl, and a ft3 result of 3.79 pg/ml.On (b)(6) 2020, the patient had a tsh result of 0.091 ¿iu/ml, a ft4 result of 1.70 ng/dl, and a ft3 result of 3.15 pg/ml.On (b)(6) 2020, the patient had a tsh result of 0.146 ¿iu/ml, a ft4 result of 1.70 ng/dl, and a ft3 result of 3.72 pg/ml.Medwatch field d11 has been updated.- attachment: [pt-43256_pt-43257_pt-43258_pt-43259.Pdf].

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9745832
• MDR Text Key: 220300722
• Report Number: 1823260-2020-00534
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2020

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 Model Number: TSH
• Device Catalogue Number: 11731459122
• Device Lot Number: 429091
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 02/06/2020
• Supplement Dates FDA Received: 03/13/2020; 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE ATTACHMENT FOR PATIENT MEDICATIONS.
• Patient Age: 7 YR