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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for three samples of the same patient tested for elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and the elecsys tsh assay (tsh) on a cobas 8000 e 602 module (e602) and a cobas e 411 immunoassay analyzer.Erroneous results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.Refer to the attachment for all patient data.Results highlighted in yellow are erroneous.Some samples from the patient were also measured on a beckman dx i800 analyzer and abbott i2000 analyzer.The customer stated that the roche method ft3 and ft4 results were much higher than those of beckman and abbott.The sixth sample was treated with polyethylene glycol (peg) and repeated on the e602 analyzer.Results from the peg treated sample were lower.The patient has a pelvic mass and is wanting surgical treatment.Based on the roche results, there was a delay in the patient's surgical treatment.No adverse events were alleged to have occurred with the patient.The patient does not have a history of hyperthyroidism.The patient does not receive l-thyroxine, biotin, or streptavidin therapy.The e602 analyzer serial number was (b)(4).The e411 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

Quality controls were stable for the ft4 assay.From the calibration and quality control data provided for the ft4 assay, a general reagent issue is not likely.For the observed differences in the ft3 and ft4 values generated with the e602 analyzer and e411 analyzer, a biological component may be present in the sample which interacts differently with the assay components during measurement on the different analyzers.This may result in discrepant values generated with larger analyzers such as the e602 versus smaller analyzers such as the e411.The presence of this biological component could also influence the measurements obtained with the roche assays, beckman assays, and abbott assays.For the differences in values obtained before and after peg treatment of the patient sample, it should be noted that results after such a treatment are not reliable and should be handled with care.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.A sample from the patient was not available for investigation, so further investigations were not possible.

Manufacturer Narrative

It has been confirmed that samples 3 and 7 are the same sample.

• Brand Name: FT4, FREE THYROXINE
• 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: 6898127
• MDR Text Key: 89476391
• Report Number: 1823260-2017-02126
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961489
• 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: 11/01/2017

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: 06437281190
• Device Lot Number: 215455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/08/2017; 09/08/2017
• Supplement Dates FDA Received: 09/28/2017; 11/01/2017
• 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: 29 YR