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

Catalog Number 07026935190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned thyroid results for 1 patient sample tested on a cobas e801 module.The customer had reported the thyroid results outside of the laboratory where the physician questioned the elecsys anti-tpo (anti-tpo) and anti-tshr results and requested the sample be investigated.The customer submitted the sample for investigation where discrepant results were identified for elecsys ft3 iii (ft3 iii), elecsys ft4 ii, elecsys tsh (tsh), anti-tpo, anti-tshr and anti-tg between the customer's e801 module, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site, the centaur method, the architect method and the yamasa method.Refer to the following related medwatch patient identifiers: (b)(6).Refer to attached data titled "patient results" for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The e602 module serial number is (b)(4).The e411 analyzer serial number was (b)(4).The e801 module serial numbers used at the investigation site were (b)(4).The anti-tpo reagent lot number used at the investigation site was 249095 with an expiration date of 30-jun-2018.

Manufacturer Narrative

Based on the available data, a general reagent issue could be excluded.There was not enough sample volume left to complete the investigation.The investigation was unable to find a definitive root cause.

• 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
• MDR Report Key: 7549440
• MDR Text Key: 109909502
• Report Number: 1823260-2018-01640
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K051890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 07026935190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALLERGY MEDICINE; FOLIC ACID SUPPLEMENT; SUNSCREEN SUPPLEMENT; VITAMIN A; VITAMIN B; VITAMIN C; VITAMIN D
• Patient Age: 33 YR