MAUDE Adverse Event Report: ROCHE DIAGNOSTICS EVO ANALYTICAL D MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number D MODULE

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

The customer received questionable high crea plus creatinine plus results for an unknown number of patient samples.The samples were repeated on an analytical p module analyzer.Of the data provided for 21 patient samples, only the result for 6 patient samples were discrepant.Refer to the attachment to the medwatch for all patient data.The results were not reported outside of the laboratory.There was no adverse event.The reagent lot number and expiration date were requested but were not provided.The field service representative could not determine a cause.He checked the sample probe and all the probes alignments, performed an air purge, rinse, and prime.He ran qc and linearity testing with all results within specifications.

Manufacturer Narrative

A specific root cause could not be identified.As the issue appeared to be resolved by switching the reagent to a different channel, a customer handling issue was suspected to be the cause.

Manufacturer Narrative

The customer stated they believed the issue was caused by creatinine plus reagent being placed on the wrong channel.They have since switched reagent to a different channel, ran linearity testing, and have not had any issues since.

• Brand Name: EVO ANALYTICAL D MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7134250
• MDR Text Key: 96033991
• Report Number: 1823260-2017-03083
• Device Sequence Number: 0
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D MODULE
• Device Catalogue Number: 05023530001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/14/2017; 12/14/2017
• Supplement Dates FDA Received: 01/11/2018; 01/29/2018
• 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