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

Catalog Number 05005256002

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

The customer received questionable results for multiple samples when whole blood samples were sent to the cobas c501 analyzer and tested.Of the data provided for two patient samples, only the ion selective electrode (ise) potassium results were discrepant.Patient sample 1 initial result was 6.15 mmol/l and the repeat result on another cobas c501 analyzer was 5.08 mmol/l.Patient sample 2 initial result was 6.09 mmol/l and the repeat result on another cobas c501 analyzer was 4.64 mmol/l.The patients were sent to the er to be redrawn.The repeat results were believed to be correct.The patients were not adversely affected.The potassium electrode lot number and expiration date were requested, but were not provided.The field service representative visited the site and collected instrument files for investigation.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Manufacturer Narrative

The investigation determined the sample rack was removed from the mpa after a reset and was not fully centrifuged.Per product labeling, any specimen removed from the mpa must be inspected by the operator and then handled appropriately.The rack should have been marked for "recentrifuge" by the customer which would have caused the rack to reload into the centrifuge.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312- 8504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4323397
• MDR Text Key: 5131883
• Report Number: 1823260-2014-09869
• 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 Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

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 Catalogue Number: 05005256002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2015
• 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
• Patient Sequence Number: 1