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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 1 patient tested for elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii) and anti-tshr on a cobas 8000 e 602 module.The customer thinks the tsh and anti-tshr results are too high and the ft4 ii results are too low.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the tsh results and medwatch with patient identifier (b)(6) for information on the ft4 ii results.Twelve days after birth: the patient underwent neonatal mass screening using mass spectrometry and the tsh result was 79 uiu/ml.The patient was tested on the e602 module with a tsh result of 2467 uiu/ml, an ft4 ii result of 0.2 ng/dl and an anti-tshr result of 4.52 iu/l.The patient was administered levothyroxine (lt4) orally due to hypothyroidism.The patient's mother has a normally functioning thyroid and the mother's anti-tshr result was "negative." twenty two days after birth: a sample from the patient was sent to an external laboratory using an unknown method and the thyroid stimulating antibody result was 266% and the tsh-stimulation blocking antibody result was 25.8%.Forty four days after birth: the patient was tested on the e602 module and the tsh result was 86 uiu/ml and the ft4 ii result was 2.29 ng/dl.Oral lt4 was increased; the customer stated the tsh result was not normal for the high ft4 ii result.One hundred twenty seven days after birth: the patient was tested on the e602 module with a tsh result of 51.4 uiu/ml, an ft4 ii result of 1.85 ng/dl and an anti-tshr result of 3.34 iu/l.The sample was repeated by the architect method and the tsh result was 33.4 uiu/ml.The patient had an anti-tshr result by an unknown method of [-] 26.1%.The results from the patient's "latest" sample on the e602 module was a tsh result of 9.69 uiu/ml, an ft4 ii result of 1.95 ng/dl and an anti-tshr result of 3.16 iu/l.The results from the e602 module were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).

Manufacturer Narrative

The sample from (b)(6) 2018 was tested by the yamasa method and the anti-tshr result was < 1.0 iu/l.

Manufacturer Narrative

The "latest" sample mentioned in the initial report was from (b)(6) 2018.The sample from (b)(6) 2018 was submitted for investigation where the sample was run twice on an e602 module with anti-tshr results of less than 0.500 iu/l.From the information provided, a general reagent issue can be excluded.Values generated using different technologies cannot be directly compared to each other.Assays from different manufacturers, in this case abbott, can generate different results.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 7897358
• MDR Text Key: 120983264
• Report Number: 1823260-2018-03219
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• 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
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 DA