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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for a total of 10 patients tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), roche diagnostics cobas elecsys anti-tpo (a-tpo), and the elecsys anti-tshr immunoassay (tras) on a cobas 6000 e 601 module (cobas e601), roche diagnostics elecsys e170 modular analytics immunoassay analyzer (modular), cobas 8000 e 602 module (e602), and an unknown roche analyzer (roche analyzer).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The erroneous results did not match results from competitor assays.It was suspected that the patient samples contained an interferent to the roche thyroid assays.This medwatch will apply to the ft4 assay, lot number 158223.Please refer to the following medwatches for information related to the other assays: refer to medwatch with patient identifier (b)(6) for information related to tsh reagent lot number 172513.Refer to medwatch with patient identifier (b)(6) for information related to tsh reagent lot number 185522.Refer to medwatch with patient identifier (b)(6) for information related to ft3 reagent lot number 179026.Refer to medwatch with patient identifier (b)(6) for information related to ft3 reagent lot number 203102.Refer to medwatch with patient identifier (b)(6) for information related to ft4 reagent lot number 180429.Refer to medwatch with patient identifier (b)(6) for information related to ft4 reagent lot number 185414.Refer to medwatch with patient identifier (b)(6) for information related to a-tpo.Refer to medwatch with patient identifier (b)(6) for information related to tras.Refer to the attachment for all patient data.Data highlighted in yellow indicates the results that were erroneous.Fields with "?" indicate that the information was asked for, but not provided.No adverse events were alleged to have occurred with the patients.The e601 analyzer serial number is (b)(4).The serial numbers of the other roche analyzers that were used were asked for, but not provided.

Manufacturer Narrative

The customer provided updated information for the 10 patients that were initially reported.Please refer to the attachment for all updated information.New or updated information is highlighted in green.The customer also provided data for 3 additional patients who had erroneous results for tsh, ft3, and ft4.These patients are identified as patients 11 through 13.A yellow "erroneous" mark next to each result row indicates which results were erroneous.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.These patients were not treated and there were no allegations of any adverse events occurring with these patients.

Manufacturer Narrative

Samples from each patient were provided for investigation.Investigations determined the following for each sample: patient 1: this sample was determined to contain an interfering factor to the tsh, ft3, and ft4 assays.This limitation is covered in product labeling.Patient 2: this sample was determined to contain an interfering factor to the tsh, ft3, ft4, and anti-tpo assays.This limitation is covered in product labeling.Patient 3: no interfering factors were detected in this sample.The differences in the ft4 values could not be explained with available methods and current state of the art.Patient 4: the high ft4 value generated at the customer site could not be duplicated.Upon further analysis, the sample was determined to contain an interfering factor to the ft3 and ft4 assays.Patient 5: this sample was determined to contain an interfering factor to the ft3, ft4, and anti-tpo assays.This limitation is covered in product labeling.Due to lack of remaining sample volume, the anti-tshr parameter could not be further investigated.Patient 6: this sample was determined to contain an interfering factor to the ft3 and ft4 assays.This limitation is covered in product labeling.Patient 7: this sample was determined to contain an interfering factor to the ft3 assay.This limitation is covered in product labeling.To the mathematical differences of the tsh and ft4 values, it needs to be taken into account that assays from different suppliers may generate different values.This relates to the overall setups of the assays, the antibodies used, and the standardization methodology/materials used.Patient 8: this sample was determined to contain an interfering factor to the tsh, ft3, and ft4 assays.This limitation is covered in product labeling.Patient 9: this sample was determined to contain an interfering factor to the ft3 and ft4 assays.This limitation is covered in product labeling.Patient 10: no interfering factors were detected in this sample.The differences in the ft4 values could not be explained with available methods and current state of the art.Patient 11: this sample was determined to contain an interfering factor to the ft3 and ft4 assays.This limitation is covered in product labeling.Patient 12: this sample was determined to contain an interfering factor to the tsh, ft3, and ft4 assays.This limitation is covered in product labeling.Patient 13: this sample was determined to contain an interfering factor to the tsh, ft3, and ft4 assays.This limitation is covered in product labeling.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.

• 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: 6512543
• MDR Text Key: 73456968
• Report Number: 1823260-2017-00856
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 158223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• 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