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 06/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of a ongoing problem with their ise indirect na, k, ci for gen.2 results from their cobas 8000 cobas ise module (double).The customer provided the sodium, potassium, and chloride results for 1 patient sample.The initial sodium result was 164 mmol/l with repeat results of 133 mmol/l and 134 mmol/l.The initial potassium result was 5.3 mmol/l with repeat results of 4.6 mmol/l and 4.6 mmol/l.The initial chloride result was 73 mmol/l with repeat results of 92 mmol/l and 93 mmol/l.The erroneous results were not released outside of the laboratory.The repeat results were deemed to be correct.There was no adverse event.After discovery of the erroneous results, qc testing was performed with acceptable results.The sodium, potassium, and chloride electrode lot information was requested but was not provided the field engineering specialist found a partially obstructed vacuum nozzle.He replaced a probe and verified the probe adjustments.He replaced two vacuum nozzles.He checked gear pump pressure, replaced all seals, checked tubing for proper installation, and he replaced pinch tubing.He verified the system was operating properly.The customer performed qc testing.The customer has had no further issues following the service visit.

• 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: 7645046
• MDR Text Key: 112568253
• Report Number: 1823260-2018-02086
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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: 06/11/2018
• 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: 39 YR