MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR); THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

Catalog Number 04388780190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

The customer reported erroneous results for two patient samples tested for antibodies to tsh receptor (anti-tshr).The results were questioned as they did not conform to test results indicating normal thyroid hormones.The samples were sent to a different hospital where the brahms method was used for repeat testing.It is unclear if results were reported outside of the laboratory.Patient sample 1 initial anti-tshr result was 3.7 iu/l.The repeat test result was <1.5 iu/l.This patient previously visited their general practitioner on three separate occasions and was tested for anti-tshr.These results were generated on a different modular e system.The results were 4.5 iu/l, 5.2 iu/l and 4.5 iu/l.On (b)(6) 2015 patient sample 2 (49 year old, gender not provided) initial anti-tshr result was 2.0 iu/l.The repeat test result was <1.5 iu/l.No adverse event occurred.The modular e module serial number was (b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

The sample from patient 1 was submitted for investigation.There is no sample left from patient 2 to investigate.Upon investigation, the presence of an interference with human anti- mouse antibodies was detected which can create false positive values.This interference is documented in product labeling.

Manufacturer Narrative

The customer provided additional patient data for patient 1.The customer provided t4 and t3 results from the patient sample obtained on (b)(6) 2015.The t4 result was 92 nmol/l and the t3 result was 2.0 nmol/l.

• Brand Name: ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR)
• Type of Device: THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
• 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: 4569360
• MDR Text Key: 5557455
• Report Number: 1823260-2015-01717
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K080092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04388780190
• Device Lot Number: 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 02/13/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 020 YR