MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS ISE MODULE (DOUBLE); 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 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable ise indirect na, k, ci for gen.2 results for one patient from the cobas 8000 cobas ise module.The initial sodium result was 166 mmol/l and the repeat result was 139 mmol/l.The initial potassium result was 5.0 mmol/l and the repeat result was 4.2 mmol/l.The initial chloride result was 82 mmol/l and the repeat result was 101 mmol/l.The erroneous results were not reported outside of the laboratory.The repeat results were believed to be correct.There was no adverse event.The electrode lot numbers and expiration dates were requested but were not provided.Calibration and qc data was acceptable and within range.The field service representative found the diluent dispense nozzle was misadjusted and he adjusted the nozzle.He also found partially occluded vacuum nozzles.He replaced the probe, verified the adjustments, replaced both vacuum nozzles, checked gear pump pressure, replaced all seals, checked tubing, and replaced pinch tubings.The customer performed successful calibration and qc.

• Brand Name: COBAS 8000 COBAS ISE MODULE (DOUBLE)
• 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: 7638899
• MDR Text Key: 112573676
• Report Number: 1823260-2018-02049
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• 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
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: 05964075001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• 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
• Patient Age: 10 MO