MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; AUTOMATED PREANALYTICAL SYSTEM

Model Number MPA

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2016

Event Type  malfunction  

Event Description

The customer complained of erroneous results for 2 patient samples tested for ise indirect na for gen.2 on a cobas 8000 cobas ise module.The erroneous results were reported outside of the laboratory.Patient 1 ((b)(6) initial na result from an aliquot off of the modular pre-analytic (mpa) instrument was 159 mmol/l.This result was reported outside of the laboratory where it was questioned by the doctor who requested a repeat.The sample from the primary tube was repeated and the result was 145 mmol/l.Patient 2 ((b)(6)) initial na result from an aliquot off of the modular pre-analytic (mpa) instrument was 156 mmol/l.The repeat result from the primary tube was 145 mmol/l.No adverse event occurred.The na electrode lot number and expiration date were not provided.The field service engineer (fse) visited the customer site and determined that the aliquot samples from the mpa had been sitting for longer than 3 hours causing the high na results.The fse identified a possible jam on the turntable of the mpa.System functionality was checked and the system was operating according to specification.Quality controls were within specification.Trace file data was provided by the customer for investigation.The investigation indicated the sample for patient 1 ((b)(6)) was accompanied by "no test selection" which stopped the sample from being run.The investigation was not able to locate any other data for this sample id.Two additional patient sample ids were provided by the customer.No results were provided.The investigation stated these 2 sample ids were processed according to specification.A device malfunction has not been identified.

Manufacturer Narrative

The connection module, connecting the mpa with the analyzer, was manually paused.The rack with samples could only go to the analyzer after the module was manually unpaused.When a connection module is paused, racks cannot pass to the connected analyzer.The system performed according to specification.There was no device malfunction.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• 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: 6212644
• MDR Text Key: 63653182
• Report Number: 1823260-2016-02067
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPA
• Device Catalogue Number: 05005256002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• 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: 55 YR