MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E801

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for three patient samples tested for the elecsys tsh assay (tsh) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 801 module (e801).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The samples were initially tested on (b)(6) 2018 and repeated on (b)(6) 2018.No units of measure were provided for the tsh assay.The first sample initially resulted with a tsh value of 1.29, repeating as 3.02.The sample initially resulted with a ft4 value of 40.5 pmol/l, repeating as 15.2 pmol/l.The second sample initially resulted with a tsh value of 0.88, repeating as 1.15.The sample initially resulted with a ft4 value of 37.2 pmol/l, repeating as 14.4 pmol/l.The third sample initially resulted with a tsh value of 1.17, repeating as 1.96.The sample initially resulted with a ft4 value of 27.6 pmol/l, repeating as 15.4 pmol/l.No adverse events were alleged to have occurred with the patients.The tsh reagent lot number was 331814.The reagent expiration date was asked for, but not provided.The ft4 reagent lot number was 303203.The reagent expiration date was asked for, but not provided.

Manufacturer Narrative

Procell is a system solution used on cobas e 801 for the transport of the assay reactant mixture to the measuring cell and for ecl signal generation.There are 2 bottles of procell ii m present on the cobas e 801: the active bottle is used for the measurements and the stand-by bottle is automatically used after the first bottle becomes empty (procell bottle changeover).Investigations by the manufacturer have shown that when this issue occurs it may cause discrepant results approximately 15 determinations after the pc bottle changeover for a period of up to 20 consecutive measurements.All customers have been provided a workaround procedure to prime the instrument when it is determined that their cobas e 801 module is potentially affected by this issue.They are also instructed to contact roche technical support.A roche field service engineer will perform the procell ii m flowpath decontamination procedure and the procedure should be performed every 4 weeks until your cobas e 801 module is switched to the improved procell ii m formulation.Improved procell ii m is available in the us and roche field service engineers are in the process of converting customers to the new procell ii m.

• Brand Name: COBAS 8000 E 801 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7649756
• MDR Text Key: 113018671
• Report Number: 1823260-2018-02109
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• 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: 04/10/2019

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: E801
• Device Catalogue Number: 07682913001
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-03/15/19-003-C
• Patient Sequence Number: 1