MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem High Test Results (2457)

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

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer had issues with questionable elecsys testosterone ii assay results for proficiency material and patient samples.Data was provided for three patient samples.Patient 1 initial result was 8.47 nmol/l and the repeat result was 2.01 nmol/l.Patient 2 initial result was 6.31 nmol/l and the repeat result was 0.64 nmol/l.Patient 3 initial result was 5.06 nmol/l and the repeat result was 0.602 nmol/l.Only the erroneous initial result for patient 2 was reported outside the laboratory.Only the repeat results were reported for patients 1 and 3.There was no allegation of an adverse event.The reagent lot number and expiration date were requested but were not provided.Multiple service visits were performed and it was determined the extra wash station (ews) sipper lines and the reagent probe were blocked.These were cleaned.It was also found that the procell syringe was contaminated and had crystallization.This was drained, removed, and cleaned.Signs of liquid and dirt were found on the valve, which was cleaned.The measuring cells were changed and new tubing, nozzles, and probes were installed.Analyzer performance testing was completed and was acceptable.

Manufacturer Narrative

The field service representative performed photomultiplier high voltage adjustment, a blank cell calibration, and calibration, qc, and precision testing.The customer stated they were still having issue with erroneous testosterone results for qc material.

Manufacturer Narrative

The field service representative checked the liquid level detection (lld) and the probe adjustments.The probe horizontal sampling position was adjusted and the syringe unit was replaced.Performance testing was completed and was acceptable.

Manufacturer Narrative

The degasser was replaced.The system was decontaminated, and no further issues were reported.A definitive root cause could not be determined.

• Brand Name: COBAS 8000 E 602 MODULE
• Type of Device: IMMUNOCHEMISTRY 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: 6903389
• MDR Text Key: 89489848
• Report Number: 1823260-2017-02144
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• 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