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

Catalog Number 03369854001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2014

Event Type  malfunction  

Manufacturer Narrative

A system support specialist visited the site and found the cause of the issue was the same rack being used twice.

Event Description

The customer received questionable results for multiple assays on the cobas 6000 for two samples that were not centrifuged by the modular preanalytic analyzer (mpa).The initial results were from the whole blood samples.The customer realized they had tested the whole blood, centrifuged the samples and repeated testing.Of the data provided, only the following results were discrepant.Patient 1 ((b)(6)): potassium: initial 59.47 mmol/l, repeat 4.55 mmol/l.Sodium: initial 85 mmol/l, repeat 141 mmol/l.Troponin t (tnt): initial 23.1, repeat 50.2.No unit of measure provided.Creatinine: initial -22 mmol/l, repeat 145 mmol/l.Patient 2 ((b)(6) year old male): c-reactive protein (crp): initial 42.0 mg/l, repeat 61.7 mg/l.Information concerning which results were reported to the physician was requested, but it was unknown.The patients were not adversely affected.The reagent lot numbers and expiration dates were requested, but were not provided.

Manufacturer Narrative

This event occurred in (b)(6).

• 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: 4266831
• MDR Text Key: 12710951
• Report Number: 1823260-2014-09143
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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: 03369854001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/02/2014
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2014
• 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
• Patient Age: 084 YR