MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C702 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 06473245001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for rheumatoid factors ii (rf-ii).The date of event was not provided.The initial result was 6 iu/ml with a data flag.The sample was repeated and the result was 0 iu/ml.The sample was repeated again using a 1:3 dilution and the result was 21 iu/ml.The result of 21 iu/ml was reported outside of the laboratory.It is not known which result was believed to be correct.The patient was not adversely affected.The rf-ii reagent lot number and expiration date were not provided.

Manufacturer Narrative

Upon further investigation, the data flag >kin associated with the result of 6 iu/ml means that the prozone check limit exceeds the specified limit.This is caused by the sample concentration being too high.High sample concentration or interferences can also cause unflagged results of zero.When a >kin flag displays the customer is advised to dilute and repeat the sample which is what the customer did.It was noted that the result of 21 iu/ml was believed to be the correct result.Calibration and quality controls were acceptable.A problem with the reagent or instrument is not likely.The most likely root cause of the erroneous low results is an unknown interference.

• Brand Name: COBAS 8000 C702 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5234496
• MDR Text Key: 31570713
• Report Number: 1823260-2015-04588
• Device Sequence Number: 0
• Product Code: DHR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 10/28/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1