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 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable high free thyroxine (ft4) results from a cobas e601 analyzer for four patient samples.After the questionable results were received, it was noted the reagent pack used for these tests had been placed onboard the analyzer on (b)(6) 2016 as a standby reagent pack, but qc was not performed on the reagent pack.On (b)(6) 2016, this reagent pack became the current pack, and the customer performed qc with results out of range.The customer calibrated the reagent pack and the calibration failed.The customer changed to a new reagent pack with lot number 188609.Calibration and qc passed and the four patient samples were repeated.Patient 1 initial result was >7.77 ng/dl, repeat result was 4.69 ng/dl.Patient 2 initial result was >7.77 ng/dl, repeat result was 1.72 ng/dl.Patient 3 initial result was >7.77 ng/dl, repeat result was 1.76 ng/dl.Patient 4 initial result was >7.77 ng/dl, repeat result was 2.09 ng/dl.The erroneous results were not reported outside the laboratory.There was no adverse event.It was determined the reagent pack in question may have been damaged as the customer noted the reagent refrigerator temperature was -4 degrees celsius which was below the acceptable range stated in product labeling.Further investigation could not determine a specific root cause.Based on the provided information, a general reagent issue could be excluded.Damage to the reagent due to the low storage temperature was the most probable cause.The reagent is very sensitive to freezing which would cause the beads to stick together and the r1 and r2 components to build up a gradient causing the reagent to not be mixed correctly.

• 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: 5894216
• MDR Text Key: 52741314
• Report Number: 1823260-2016-01250
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 08/22/2016

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: 125827
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 08/22/2016
• 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