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 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous high results for a total of five patient samples tested for the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).The customer stated that some erroneous values were reported outside of the laboratory and amended.The customer could not specify which values were reported outside of the laboratory.The first sample initially resulted as 28.87 pmol/l and repeated as 18.73 pmol/l.The second sample initially resulted as 72.45 pmol/l and repeated as 58.91 pmol/l.The third sample initially resulted as 31.8 pmol/l and repeated as 13.5 pmol/l.The fourth sample initially resulted as 89.20 pmol/l and repeated as 39.3 pmol/l.On (b)(6) 2017, field service engineer cleaned a wash station waste line and replaced the reagent probe since it was intermittently sticking in the upper position.He replaced seals and pinch tubing.He checked for materials in the incubator and ran performance testing.He noted that precision looked good in the performance test, but some values for another parameter were poor.He ran quality controls.After the service visit, the customer stated that they had erroneous results for an additional 3 patient samples.The customer provided data for one of these additional samples (sample 5).On (b)(6) 2017, this fifth sample initially resulted as 28.57 pmol/l and repeated as 14.98 pmol/l.No adverse events were alleged to have occurred with the patients.The ft4 reagent lot number was 24682500, with an expiration date of 30-jun-2018.

Manufacturer Narrative

The field service engineer was on site and resolved all technical issues.The customer has reported no further incidents since this visit.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.The cause of the issue may be related to pre-analytic sample handling.

• 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: 6945060
• MDR Text Key: 90406942
• Report Number: 1823260-2017-02294
• 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: 11/01/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 11/01/2017
• 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