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 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received an erroneous result for one patient sample tested for ca2 calcium gen.2 (ca) on a cobas integra 400 plus (i400+).An erroneous value was reported outside of the laboratory to the doctor.No issues were encountered with any other assays.The sample initially resulted as 13.51 mg/dl.The sample was repeated, resulting as 9.82 mg/dl.The primary sample tube was used for both measurements.No adverse events were alleged to have occurred with the patient.The ca reagent lot number was 20864301, with an expiration date of 03/30/2018.The customer cleaned up the reservoir on the instrument and the water conductivity was checked.The field service engineer stated that the probes and wash tower of the analyzer appear clean, but the customer does not clean these regularly.He checked special wash programming and all of the parameters were active.There were no non-roche reagents installed on the analyzer.Precision studies were performed and these were ok.Quality controls were ok, except for one outlier on (b)(6) 2017.Calibration data was ok.

Manufacturer Narrative

Upon review of the alarm trace, there were no pertinent alarms on the date of the event, but there were frequent alarms indicating that there was low or no sample volume.It may be possible that the sample tube settings on the analyzer are not matching the actual fill volume of the sample tubes.This would cause the probe to dive too deeply into the sample.Per operating instructions, only one type of sample tube or cup must be used for each rack.A mixture of tube types must not occur on the same rack.Based upon provided information, a general reagent problem could be ruled out since calibration and controls were acceptable.Upon review of the result reaction monitor, no interference was observed.The issue appears to be related to maintenance of tube settings.

• 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: 6631043
• MDR Text Key: 77619240
• Report Number: 1823260-2017-01204
• Device Sequence Number: 0
• Product Code: CJY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• 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