MAUDE Adverse Event Report: ROCHE DIAGNOSTICS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number 12017709122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

The customer received questionable results for thyroxine (t4), thyrotropin (tsh), and t-uptake (t-up) on one patient sample, and erroneous t4 results on a second patient when testing was performed on cobas e411 rack instrument with serial number (b)(4).Patient 1 had erroneous t4, tsh and t-up results that were reported outside of the laboratory, with no adverse events.These results were reported on the mdr with submission number 1823260-2014-02769.Please see the attachment to the mdr for a copy of these results.No further samples for patient 1 could be provided for evaluation; therefore a specific root cause could not be identified.Patient 2 had erroneous t4 results that were reported outside of the laboratory, with no adverse events.These data were reported on the mdrs with submission numbers 1823260-2014-02769 and 1823260-2014-02770.Please see the attachment to the mdr for a copy of these results.A specific root cause could not be identified.On (b)(6) 2014, patient 2 returned and had a new sample drawn, which generated erroneous t4 results on this instrument and another instrument.The t4 result from this instrument was 21.7 ug/dl, which was reported to the physician.On (b)(6) 2014, the sample was sent to a sister facility and was run on a cobas 6000 e601 instrument and generated a result of 20.0 ug/dl.The sample was then sent to another laboratory where it was run on a siemens instrument and generated a result of 12.7 ug/dl.The customer believed the results from the other methodology to be correct.There was no adverse event.The customer believes the erroneous results are due to some interference in the sample and refused a service dispatch.The (b)(6) 2014 sample from patient 2 was requested for further evaluation.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Manufacturer Narrative

On follow up with the customer, they indicated that patient 2 is taking a vitamin d supplement and birth control pills.The patient also had additional thyroid results that were generated on this instrument on (b)(6) 2014.The patient had a "t3" result of 184 ng/dl, a t-uptake result of 1.5 tbi, a tsh result of 0.263 uiu/ml and a "t4, free" result of 1.5 ng/dl.(b)(6).

Manufacturer Narrative

The investigation determined that no interfering factors seemed to be present in the investigated sample.It was also determined that no interference from pharmaceuticals seemed to be present either.A general reagent issue was excluded.The difference between the elecsys and other assays could possibly be attributed to differences in methods and instruments, differences in standardization and applications and different antibodies.

Manufacturer Narrative

Additional testing was performed during the investigation on the sample for patient 2: anti-tg: 58.02 iu/ml anti-tpo: 86.69 iu/ml.

• Brand Name: T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3816208
• MDR Text Key: 4451035
• Report Number: 1823260-2014-03479
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 12017709122
• Device Lot Number: 17416501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/23/2014
• 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
• Patient Sequence Number: 1
• Treatment: PATIENT 2 - APRI; PATIENT 2 - PROPRANOLOL HCL 10 MG; PATIENT 2 - SPIRONOLACTONE 150 MG