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

Catalog Number 04388780160

Device Problem High Test Results (2457)

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

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that controls run at the end of a run for the elecsys anti-tshr immunoassay (anti-tshr) were outside of range on a cobas 6000 e 601 module (e601).The customer made fresh controls and re-tested them, but recovery was still outside of range.The customer then placed a fresh reagent pack on board and controls recovered fine.The customer stated that 85 patient samples had questionable anti-tshr results.The customer provided data for one patient sample that had an erroneous initial result that was reported outside of the laboratory.The sample initially resulted as 2.22 iu/l.The sample was repeated with the new reagent pack and the result was 0.983 iu/l.The repeat result was believed to be correct and a corrected report was issued.The customer stated that she has not heard of any patients being treated based on the affected results.No adverse events were alleged.The e601 analyzer serial number was (b)(4).The field service engineer determined that a rinse station on the analyzer was not draining properly.He bleached the rinse station.He ran performance testing and this was within specifications.He verified that the rinse station was draining properly.

Manufacturer Narrative

The sample was repeated on (b)(6) 2017.Upon investigation, the alarm trace showed that there was a changeover of a system reagent and an abnormal sample aspiration alarm on (b)(6) 2017.The first level of control was out of range on (b)(6) 2017.The second level of control was out of range on (b)(6) 2017.All other values were found to be within range.No reagent shipping or storage issues were noted at the customer site.A general reagent issue can most likely be excluded.Reagent transportation/storage and a hardware issue can also most likely be excluded.The issue with the reagent pack may have been caused by a reagent handling issue at the customer site.It is also possible that contamination of the reagent pack with foreign matter occurred.

• Brand Name: ELECSYS ANTI-TSHR IMMUNOASSAY
• 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: 6523551
• MDR Text Key: 73806490
• Report Number: 1823260-2017-00906
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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 Expiration Date: 01/31/2018
• Device Catalogue Number: 04388780160
• Device Lot Number: 19046801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• 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