MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR; ANTI-TSHR IMMUNOASSAY

Catalog Number 08496633190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable thyroid results for one patient from cobas e 801 module serial number (b)(4).The customer retested the sample by accuraseed (wako) method, with peg treatment, and tsh assay with dilutions.The sample was submitted for investigation where it was tested on a cobas e 801 module.This mdr is for the anti-tshr assay.Refer to the medwatchs with patient identifiers (b)(6) for the other assays involved.The customer reported out the results to a physician and asked for repeat testing.

Manufacturer Narrative

Sample from the patient was submitted for investigation.An interfering factor against streptavidin which is a component of the reagent was found in the sample.This interfering factor is documented in product labeling for the assay: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.

Manufacturer Narrative

Additional results were provided for the patient: from the original sample 1, the customer's anti-tshr result was 15.0 iu/l.The result by the wako method was <1.0 iu/l.A new sample 2 was drawn from the same patient on (b)(6) 2020.From the elecsys method, the results were tsh: 1.290 uiu/ml, ft4: 2.77 ng/dl, and ft3 5.17 pg/ml.From the wako method, the results were tsh: 1.014 uiu/ml, ft4: 1.31 ng/dl, and ft3 2.80 pg/ml.

Manufacturer Narrative

Additional results were obtained upon retesting the samples on(b)(6)-2022.From the original sample 1 drawn on (b)(6)-2020: the elecsys ft4 result was 2.30 ng/dl, ft3 result was 4.92 pg/ml, and anti-tshr result was 15.2 iu/l.The wako ft4 result was 1.35 ng/dl and ft3 result was 2.72 pg/ml.From the new sample 2 was drawn from the same patient on (b)(6)-2020.The elecsys ft4 result was 2.44 ng/dl, ft3 result was 5.18 pg/ml, and anti-tshr result was 15.5 iu/l.The wako ft4 result was 1.45 ng/dl and ft3 result was 3.04 pg/ml.

Manufacturer Narrative

Upon further investigation, an interfering factor against streptavidin which is a component of the reagent was found in the sample.This interfering factor is documented in product labeling for the assay: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by a suitable test design.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Type of Device: ANTI-TSHR IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10147855
• MDR Text Key: 203510004
• Report Number: 1823260-2020-01439
• Device Sequence Number: 1
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/01/2022

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: 08496633190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 05/20/2020; 04/07/2022; 05/10/2022; 06/14/2022
• Supplement Dates FDA Received: 08/21/2020; 04/28/2022; 06/02/2022; 07/01/2022
• 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: A
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male