MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR; ANTI-TSHR IMMUNOASSAY

Catalog Number 04388780190

Device Problem High Test Results (2457)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer claimed a patient had "false positive" results for elecsys ft3 iii and elecsys anti-tshr immunoassay where the results from a centaur analyzer were "negative".Data from the roche device was requested but was not provided.The results from the centaur analyzer were: tsh: >150 mu/l (range 0.35 - 5.50), ft4: 0.32 ng/dl (range 0.83 - 1.43) and 4.13 pmol/l (range 10.7 - 18.4), ft3: 2.10 pg/ml (range 3.00 - 4.70) and 3.23 pmol/l (range 4.62 - 7.24), atpo(anti-thyroid peroxidase): 1986 u/ml (range < 60.0), tsi (thyroid stimulating immunoglobulin): 0.10 iu/l (range < 0.55).Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown.There was no allegation of an adverse event.The customer used a cobas 6000 e 601 module.The serial number was requested but was not provided.Refer to the medwatch with patient identifier (b)(6) for the other assay involved.

Manufacturer Narrative

Additional information concerning the patient was received.The date of the event was actually (b)(6) 2017.The sample from (b)(6) 2017 tested by the customer on the cobas 6000 e 601 module gave the following results.This is the same sample that was then tested on a centaur analyzer.Tsh: 80.4 mu/l.Ft4: 14.4 pmol/l.Ft3: 12.5 pmol/l.Anti-tpo: >600 ku/l.Anti-tg: 3732 ku/l.Anti-tshr: 6.8 u/l.All medwatchs for this event include patient identifiers (b)(6).

Manufacturer Narrative

Sample from the patient was submitted for investigation and an interfering factor was found that reacts with the reagent which affects the sample results.Product labeling for the assay documents this interference.The incidence rate of the identified interfering factor is monitored on a quarterly basis.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Type of Device: ANTI-TSHR IMMUNOASSAY
• 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: 6674085
• MDR Text Key: 78610269
• Report Number: 1823260-2017-01355
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K080092
• 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,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• 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: 14 YR