MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number COBAS 8000 CORE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of questionable ca2 calcium gen.2 results (ca2) for multiple patients from their cobas 8000 core unit.The customer provided the ureal urea/bun results for 6 patients sample and the ca2 results for 16 patients samples.Of the data provided, 12 patient's ca2 results were reportable malfunctions.The customer stated that on (b)(6) 2018 they noted that the water quality for their system was low.The water quality from the unit was 7 ohm with a permiate level equal to 37.The analyzer had been switched off, but was inadvertently turned back on again on (b)(6) 2018.The erroneous results were not released outside of the laboratory.There was no allegation of an adverse event.A field engineering specialist visited the customer site 15-jun-2018.The investigation is currently ongoing.

Manufacturer Narrative

The root cause of the issue was determined to be insufficient water quality, the conductivity of the water was too high.The water system was repaired by the water company.The customer stated that since having their issue with their water system resolved, that there have been no further issues.

• Brand Name: COBAS 8000 CORE UNIT
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7650270
• MDR Text Key: 112727443
• Report Number: 1823260-2018-02131
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K100853
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COBAS 8000 CORE
• Device Catalogue Number: 05641446001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1