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

Catalog Number 04388780190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of discrepant results for 1 patient sample tested for elecsys anti-tshr immunoassay (anti-tshr) between the undiluted sample and the results after dilutions.The initial result was 39 iu/l.The sample was repeated with a x5 dilution and the result was 84 iu/l.The sample was repeated with a x10 dilution and the result was 112 iu/l.The sample was repeated with a x50 dilution and the result was 154 iu/l.None of these results were reported outside of the laboratory.The customer had tested the same patient approximately 1 month prior to this event and the initial anti-tshr result was < 40 iu/l.The repeat from an unknown dilution factor was 139 iu/l.The result of 139 iu/l was reported outside of the laboratory.There was no allegation that an adverse event occurred.The instrument type and serial number was not provided.The customer wondered if there was a non-specific reaction occurring in the patient sample affecting the anti-tshr results.

Manufacturer Narrative

From the information provided, a general reagent issue can be excluded.The issue with the linearity between an undiluted sample and a diluted sample relates to the fact that auto-antibodies can be heterogeneous leading to non-linear dilution effects.This is documented in product labeling for the assay.A product problem was not found.

Manufacturer Narrative

The customer also sent either the patient sample from (b)(6) 2018 for testing by another method.The anti-tshr result from the radio receptor method was 107.4 iu/l.It not known if the sample was diluted or not.The qc and calibration data at the investigation site were acceptable.From the information provided, a general reagent issue can be excluded.The issue with the linearity between an undiluted sample and a diluted sample relates to the fact that auto-antibodies can be heterogeneous leading to non-linear dilution effects.This is documented in product labeling for the assay.Assays from different manufacturers can produce different results.A product problem was not found.

Manufacturer Narrative

The customer diluted the sample with low serum human serum.The patient sample from (b)(6) 2018 was submitted for investigation.The investigation reproduced the customer's results: the initial result was 38.23 iu/l.The sample was repeated with a x5 dilution and the result was 86.30 iu/l.The sample was repeated with a x10 dilution and the result was 109.2 iu/l.The sample was repeated with a x50 dilution and the result was 133.5 iu/l.A new sample from the patient was obtained on (b)(6) 2018 and submitted for investigation: the initial result was 31 iu/l.The sample was repeated with a x5 dilution and the result was 54.9 iu/l.The sample was repeated with a x10 dilution and the result was 61.4 iu/l.The sample was repeated with a x50 dilution and the result was 77.0 iu/l.The sample was repeated with a x100 dilution and the result was 98.8 iu/l.The customer also submitted a sample from a different patient for investigation obtained on (b)(6) 2018: the initial result was 33.3 iu/l.The sample was repeated with a x5 dilution and the result was 31.5 iu/l.The sample was repeated with a x10 dilution and the result was 29.2 iu/l.The sample was repeated with a x50 dilution and the result was 46.5 iu/l.No patient information was provided for this sample.A cobas 8000 e 602 module with serial number (b)(4) was used at the investigation site.The anti-tshr reagent lot number at the investigation site was 307888.

• 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
• MDR Report Key: 7586064
• MDR Text Key: 110581141
• Report Number: 1823260-2018-01819
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K080092
• 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,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04388780190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR