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 Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The qc and calibrations were within acceptable limits without alarms.The investigation is ongoing.

Event Description

The initial reporter received questionable anti-tshr, antibodies to tsh receptor results for 3 patients on a cobas 6000 e 601 module, serial number (b)(4).Patient 1: the initial result was 163.5 iu/l.On 25-june-2020 the sample was repeated on a cobas e 411 analyzer and the result was 36.79 iu/l.Patient 2: the initial result was 6.51 iu/l.On 25-june-2020 the sample was repeated on a cobas e 411 analyzer and the result was <0.8 iu/l.Patient 3: the initial result was 6.96 iu/l.On 25-june-2020 the sample was repeated on a cobas e 411 analyzer and the result was <0.8 iu/l all of the initial results were reported outside of the laboratory to the physician.

Manufacturer Narrative

The investigation found beads in the lid of the alleged reagent pack indicating a reagent handling issue.New reagent packs of this lot performed as expected at the customer's site.Based on the available data, a general product problem could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 10319510
• MDR Text Key: 200837364
• Report Number: 1823260-2020-01787
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K080092
• 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: 08/19/2020

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: 04388780190
• Device Lot Number: 438250
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1