MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS ISE MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number COBAS 8000 ISE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable ise indirect gen.2 results for one patient sample from a cobas 8000 cobas ise module.The sodium results were 124, 143, 144 mmol/l.The chloride results were 130, 105, 107 mmol/l.Information concerning if any erroneous result was reported outside of the laboratory was requested, but it was unknown.There was no allegation of an adverse event.The electrode lot numbers and expiration dates were requested but were not provided.The investigation was unable to find a definitive root cause.

• Brand Name: COBAS 8000 COBAS ISE 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: 7595577
• MDR Text Key: 110869897
• Report Number: 1823260-2018-01882
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100853
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COBAS 8000 ISE
• Device Catalogue Number: 05641497001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• 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