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 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

The customer received questionable thyroid results for one patient which did not fit the clinical status of the patient and alleged there were patient-specific interfering factors.The customer used cobas e602 serial number (b)(4).Refer to the attachment to the medwatch for all patient data.Of the data provided, only the results for the elecsys tsh assay, anti-tpo, and anti-tshr assays were a reportable malfunction.Refer to the medwatch with patient identifiers (b)(6) for the other assays involved in the complaint.The results were reported outside the laboratory and the physician did not believe the results.Due to the elevated tsh, ft4 and ft3 results, the doctor assumed a pituitary gland issue which has not yet been analyzed or officially diagnosed.The patient was not adversely affected.Sample drawn from the patient on (b)(6) 2016 was submitted for investigation and an interfering factor to streptavidin was found in the sample.This interfering factor caused the different values for the ft4 and ft3 assays and is documented in product labeling.Review of the provided calibration and qc results did not indicate a reagent issue.

Manufacturer Narrative

Further investigation of the sample confirmed the interfering factor to streptavidin found in the sample caused the different values for the anti-tpo assay.This interference is documented 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 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: 6033433
• MDR Text Key: 57629422
• Report Number: 1823260-2016-01579
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2016
• 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