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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer questioned high free thyroxine (ft4 ii) and free triiodothyronine (ft3) results from multiple patient samples who had normal tsh levels.The ft4 ii and ft3 results do not fit the patient's clinical history.The customer also complained that there were erroneous ft4 ii and ft3 results when comparing the same samples on a siemens centaur analyzer.The customer switched from a siemens method to the roche method for thyroid parameters and was not expecting the difference he is noticing.This medwatch will cover ft4.Refer to medwatch with (b)(4) for information on the ft3 erroneous results.The customer ran approximately 3,278 routine patient samples on the e602 analyzer and repeated the samples on the siemens centaur analyzer.These were random patient samples from a one week period between (b)(6) 2015 that had normal tsh results.The customer has not complained about a specific sample, only about the elevated results he is noticing when comparing between methods.Out of these routine patient samples the customer identified approximately 100 ft4 ii values from the e602 analyzer that were > 1.8 ng/dl and 26 ft4 ii values that were > 2.0 ng/dl.The customer identified 12 ft4 values from the siemens centaur analyzer that were > 1.8 ng/dl and no ft4 values > 2.0 ng/dl.Out of the same routine patient samples the customer identified approximately 14 ft3 values from the e602 analyzer that were > 4.5 pg/ml.The customer identified 4 ft3 values from the siemens centaur analyzer that were > 4.2 pg/ml.The specific comparison data for both ft4 ii and ft3 tests run on the e602 analyzer compared to the siemens centaur has been requested but not.The results from the e602 analyzer were reported to different physicians who did not trust the results and asked for repeat testing to be performed on the different system.It is not known which results for which patient were reported outside of the laboratory.On (b)(6) 2015, after the initial point of contact, additional comparison tests were performed with additional patient samples between the e602 analyzer and the centaur analyzer.The results from the e602 analyzer were provided.See the second attachment to the medwatch for these results.The comparison results from the siemens centaur analyzer were not provided.This information has been requested.No adverse event occurred.The e602 analyzer serial number was not provided.The ft4 lot numbers in use at the time of the event were 187609 and 186893.Expiration dates were not provided.It is unclear which results were generated with which lot number.

Manufacturer Narrative

The customer clarified that the ft4 ii and ft3 values generated for their analysis were from samples measured either on the roche instrument or the siemens centaur instrument.The samples were not compared between instruments.

Manufacturer Narrative

Based on the information provided, a general reagent issue most likely can be excluded.Upon a further investigation of the data provided by the customer, a different sample pool was measured with the roche and siemens analyzers.A 1:1 comparison between the two analyzers was not performed.A 1:1 comparison of a statistically valid number of samples is needed for a solid and robust method comparison.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5192286
• MDR Text Key: 29984920
• Report Number: 1823260-2015-04422
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2015

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: Other
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2015; 12/29/2015
• 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