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 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for two patient samples tested for the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).The erroneous initial results were reported outside of the laboratory and later amended to the correct results.The first sample initially resulted as 26.3 pmol/l and repeated as 15.67 pmol/l.The second sample, from a (b)(6) year old male patient, initially resulted as 30.7 pmol/l and repeated as 23.7 pmol/l.No adverse events were alleged to have occurred with the patients.The ft4 reagent lot number was 246825.The reagent expiration date was asked for, but not provided.The field service engineer checked the analyzer and ran performance testing.

Manufacturer Narrative

The calibration signals for the reagent lot number that was used were ok.Previous calibrations showed a considerable number of failed/incorrect runs.The observed failures most likely indicate incorrect handling of the calibrator solution or the use of an incorrect calibrator solution.On the day of the event, there were failed quality control runs for two levels of control.It was not known if the failures occurred before or after the sample measurements.The field service engineer (fse) performed several service actions and ran performance testing on the analyzer on (b)(6) 2017.This performance testing was not within specifications.The fse later went on site and resolved all technical issues.No further issues were noted by the customer after this.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.A general reagent issue can most likely be excluded.Possible root causes include sample quality or the presence of bubbles/foam on reagent surfaces.

• 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: 6965760
• MDR Text Key: 90687604
• Report Number: 1823260-2017-02389
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR