MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 800; CLINICAL CHEMISTRY ANALYZER

Model Number I800

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received nineteen questionable patient results for rf-ii rheumatoid factors ii on (b)(6) 2017.The initial results were reported outside of the laboratory.The customer had to send out corrected reports for nineteen patients.Of the data provided, fifteen patient samples had discrepant results.Please see the attachment to this medwatch for relevant discrepant patient data.The repeat data was deemed to be correct.At this time there is no information to reasonably suggest that there was any adverse event.The information has been requested but has yet to be received from the customer.The rf-ii rheumatoid factors ii reagent lot number and expiration were ask for but not provided.The customer found a reagent probe that was loose and was leaking onto the reagent cassette area.The customer tightened the probe fitting and believes the issue has been resolved.The field engineering specialist was dispatched and found no other issues with the analyzer.He performed a check test, optics check, a workstation accuracy check, and a rf-ii rheumatoid factors ii precision run all which passed.

Manufacturer Narrative

The problem was identified as a user error.The customer stated that a reagent probe was loose.A field engineering specialist was onsite about 2 weeks after the event and verified the instrument is functioning correctly.He could not verify if the probe was initially loose as the customer had already fixed the error.Additional information was requested but was not provided.Case has been solved locally and no evidence of a systemic failure of a roche product was identified.

• Brand Name: COBAS INTEGRA 800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6823472
• MDR Text Key: 86165889
• Report Number: 1823260-2017-01828
• Device Sequence Number: 0
• Product Code: DHR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I800
• Device Catalogue Number: 28122474001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• 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