MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer initially reported that they received implausible ft4 values for multiple samples from the same patient tested on an e module analyzer.The values did not fit the patient's clinical history and the values could not be reproduced using an ria test method.Other results obtained with elecsys methods were also stated to be implausible for this patient and were not what was to be expected for the patient's clinical condition.The other tests include free triiodothyronine (ft3), free thyroxine (ft4), thyrotropin (tsh), antibodies to tsh receptor (trak), antibodies to thyroid peroxidase (tpo-ak), thyroglobulin (tg), and antibody to thyroglobulin (tgak) results.It was stated that the ft3, ft4, trak, rpo-ak, and tgak results were implausibly high.Tg and tsh values were found to be implausibly low.Values of ft3, ft4, tsh, trak, and tgak were found within normal range when samples were measured with an ria method.Normal values are expected for the patient's clinical condition.The questioned results were incidental findings after preoperative determination of thyroid hormones for resection of adenocarcinoma in the distal ascending colon.At this time, the patient was hospitalized.The patient was diagnosed with hyperthyroidism based on initial laboratory results and was treated with thiamazole.The free sd hormones were seen to have decreased in the course of treatment.It was stated that: "due to the non-corresponding suppressed tsh levels the alpha-subunit was determined due to suspicion of a tshom.No confirmation of suspicion was achieved." the patient did not show any symptoms of hyperthyroidism.After sonographic examination of the thyroid gland and examination of thyroid parameters, it was determined that there was no evidence of thyroid disease.The patient's hormones and antibodies are normal, the thyroid gland was not enlarged, there was no hypervascularization, and there were no knots.Of the mentioned tests, results obtained with the tsh, trak, tpo-ak, and tgak tests are reportable as a malfunction.All results obtained with elecsys methods were reported outside of the laboratory to a physician.The physician did not trust the results and requested for two samples from the patient, one tested on (b)(6) 2015 and one tested on (b)(6) 2015, to be tested using the ria method.The (b)(6) 2015 samples were repeated using the ria method.This medwatch will cover tpo-ak.Refer to the medwatch with patient identifier (b)(6) for information related to tsh.Refer to the medwatch with patient identifier (b)(6) for information related to trak.Refer to the medwatch with patient identifier (b)(6) for information related to tgak.Refer to the attachment for all test results.The patient was not adversely affected.The e module serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.A sample from the patient was provided for investigation.During investigations, the tsh, trak, tpo-ak, and tgak values measured at the customer site were confirmed.An interfering factor which interferes with the streptavidin present in the ft3 and ft4 reagents was found to be present in the sample.This same interfering factor most likely caused the falsely elevated tpo-ak values.This limitation is covered in product labeling.

• Brand Name: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 5220316
• MDR Text Key: 31013422
• Report Number: 1823260-2015-04528
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051890
• 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
• Report Date: 12/01/2015

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: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• 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
• Patient Age: 075 YR