MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MODULAR CORE WITH 1 ISE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 03340082001

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for chloride on a modular core instrument with 1 ise module compared to a different method.No erroneous results were reported outside of the laboratory.The chloride result from the roche ise instrument was 98 (unit of measure not provided).The repeat result from the radiometer abl method was 108 (unit of measure not provided).There was no allegation that an adverse event occurred.The chloride electrode lot number and expiration date were not provided.A specific root cause was not identified.Additional information was requested for investigation but was not provided.

• Brand Name: MODULAR CORE WITH 1 ISE
• 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: 6746314
• MDR Text Key: 81190366
• Report Number: 1823260-2017-01535
• Device Sequence Number: 0
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K953239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/27/2017

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 Catalogue Number: 03340082001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/27/2017
• 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