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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous high results for ten patient samples tested for the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).The high values were noticed after the reagent pack had been changed.It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The customer checked calibration and found that the calibration did not pass.The customer changed the calibrator, but there was no change.The customer then changed the reagent pack and the issue was no longer observed.The affected samples were repeated after changing the reagent pack.The first sample initially resulted as 1.69 ng/dl and repeated as 1.13 ng/dl.The second sample initially resulted as 1.85 ng/dl and repeated as 1.23 ng/dl.The third sample initially resulted as 1.97 ng/dl and repeated as 1.32 ng/dl.The fourth sample initially resulted as 1.36 ng/dl and repeated as 0.91 ng/dl.The fifth sample initially resulted as 1.98 ng/dl and repeated as 1.33 ng/dl.The sixth sample initially resulted as 2.15 ng/dl and repeated as 1.40 ng/dl.The seventh sample initially resulted as 2.70 ng/dl and repeated as 1.80 ng/dl.The eighth sample initially resulted as 2.50 ng/dl and repeated as 1.67 ng/dl.The ninth sample initially resulted as 1.49 ng/dl and repeated as 1.04 ng/dl.The tenth sample initially resulted as 1.81 ng/dl and repeated as 1.26 ng/dl.No adverse events were alleged to have occurred with the patients.The e602 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

The calibration signals generated with the complained reagent pack were lower than expected ranges.The pack was provided for investigation where calibration and control measurements of the pack were compared to results from a retention reagent pack.From this investigation, it was concluded that there was no issue with the performance of the complained reagent pack.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.Given the low calibration signals measured by the customer, it is possible that either the calibrator material was deteriorated or the reagent pack was not yet fully at room temperature when performing the calibrations and initial measurements at the customer site.

• 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: 6950930
• MDR Text Key: 90532449
• Report Number: 1823260-2017-02313
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: 246825
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 12/13/2017
• 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