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

Catalog Number 11731297122

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer questioned results for 1 patient sample tested for free thyroxine (ft4), thyrotropin (tsh) and thyroxine (t4).The results for ft4 and tsh were erroneous.No erroneous results were reported outside of the laboratory.The customer thinks there could be a biotin interference.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results.The initial ft4 result from the e602 analyzer was 2.97 ng/dl.The repeat result from the (b)(6) method was 1.46 ng/dl.The initial tsh result from the e602 analyzer was 0.454 miu/l.The repeat result from the (b)(6) method was 0.69 miu/l.Dilution testing was performed with tsh with the e602 and the (b)(6) method: the e602 tsh dilutions (units miu/l: x2 tsh = 0.29 x2 = 0.58.X4 tsh = 0.166 x4 = 0.664.X8 tsh = 0.091 x8 = 0.728.X16 tsh = 0.047 x16 = 0.752.X32 tsh = 0.023 x32 = 0.736.The (b)(6) tsh dilutions (units miu/l): x2 tsh = 0.332 x2 = 0.664.X4 tsh = 0.165 x4 = 0.66.X8 tsh = 0.089 x8 = 0.712.X16 tsh = 0.035 x16 = 0.56.X32 tsh = 0.017 x32 = 0.544.No adverse event occurred.The e602 analyzer serial number was (b)(4).A specific root cause could not be identified.The sample was requested for further investigation; however, the sample is not available to complete the investigation.

• 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: 5441116
• MDR Text Key: 38998770
• Report Number: 1823260-2016-00170
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11731297122
• Device Lot Number: 187612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• 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
• Patient Age: 38 YR