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

Model Number I400+

Device Problem Low Test Results (2458)

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

Event Date 01/17/2017

Event Type  malfunction  

Event Description

The customer complained of erroneous results for 1 patient sample tested for k+ electrode (k) on a cobas integra 400 plus.The erroneous results were reported outside of the laboratory.The initial k result was 5.8 mmol/l with a data flag.The sample was repeated and the repeat result of 3.5 mmol/l.The result of 3.5 mmol/l was accepted in their system reported outside of the laboratory since this was a normal result.While approving other results, the customer realized she had not received the repeat results for review.The customer pulled the sample tube and repeated the testing and obtained a result of 5.8 mmol/l with a data flag.All tests ordered for this patient were then repeated.All other repeat tests corresponded to the initial results for the patient.A k result of 5.8 mmol/l was reported outside of the laboratory as a corrected result and the ordering physician was notified.On (b)(6) 2017, the customer performed a 10 cup precision test on the sample and all results were stable at 5.6 mmol/l.The patient was not treated based on the result initially reported outside of the laboratory.The customer has not been notified of any problems.No adverse event was reported.The k electrode lot number was 215621-47.This electrode expires 03/03/2017.Calibration and controls were acceptable prior to testing.The field service engineer (fse) visited the customer site and no issues were identified.The operation of the instrument was checked.The customer ran calibration, quality controls, and a precision check.All results were acceptable.Based on the information provided for investigation, the results of 5.8 mmol/l and 5.6 mmol/l are believed to be correct since the results were repeated several times.The result of 3.5 mmol/l was only obtained one time.A specific root cause could not be identified.Additional information was requested for investigation but was not provided.Since the patient was not tested for chloride, it is not possible to determine if the discrepant results were due to ise flow issues or pre-analytical problems.

Manufacturer Narrative

The customer has not had any further problems.

• 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: 6314060
• MDR Text Key: 67215951
• Report Number: 1823260-2017-00254
• Device Sequence Number: 0
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2017

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: 03245233692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/07/2017; 03/08/2017
• 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
• Patient Age: 73 YR