MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number I400+

Device Problem High Test Results (2457)

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

Event Date 10/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of an erroneous high result for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas integra 400 plus.The initial gluc3 result was 193.37 mg/dl.This result was reported outside of the laboratory.The patient requested that the sample be repeated.The customer repeated the sample twice with results of 103.88 mg/dl and 103.93 mg/dl.There was no allegation that an adverse event occurred.The gluc3 reagent lot number was 23629001 with an expiration date of 31-jul-2017.On (b)(6) 2017 the customer also had issues with high ldl results; however these results were not discrepant.Calibration and quality controls (qc) were acceptable.During a review of the alarm trace, frequent "no fluid/not enough" alarms occurred.Based on this alarm, it is possible that the sample probe transferred an incorrect amount of sample volume causing a higher level.It is possible the tube settings do not match the filling volume which can cause the sample probe to go too far into the sample.Product labeling states only one type of sample tube or cup can be used in each rack.Different tube types must not be mixed on the same rack.The customer has checked their rack settings and they seem to be correct.The customer uses a clotting time of 20 minutes which was most likely too short.Based on the information available, a general reagent problem can be ruled out since calibration and qc were acceptable.

Manufacturer Narrative

The field service engineer (fse) visited the customer site and performed preventive maintenance.A specific root cause was not identified.An instrument hardware problem was not identified.Insufficient instrument maintenance cannot be excluded as a possible root cause.The system is performing as expected after the preventive maintenance by the fse.

• Brand Name: COBAS INTEGRA 400 PLUS
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6982796
• MDR Text Key: 90951491
• Report Number: 1823260-2017-02432
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K951595
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2017
• 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