MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem Low Test Results (2458)

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

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer obtained a questionable low test result for one patient sample using the crpl3 c-reactive protein gen.3 (crpl3) assay on the cobas 6000 c (501) module.All results are in units of mg/l, and all were released outside of the laboratory.The initial crpl3 result was 1.This result was automatically sent to the physicians.The customer noticed that the results for other tests for this patient had unspecified alarms, so the customer repeated the sample.The crpl3 result was 334.7.No other result data was provided.There was no allegation that an adverse event occurred.The crpl3 reagent lot number and expiration date were not provided.Investigation activities are ongoing.

Manufacturer Narrative

Quality control and precision testing information were acceptable.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The most likely root cause for the non-reproducible low discrepant result was a partially blocked sample probe.

• Brand Name: COBAS 6000 C (501) MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• 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: 6677236
• MDR Text Key: 78729821
• Report Number: 1823260-2017-01370
• Device Sequence Number: 0
• Product Code: DCN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060373
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• 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: 12 MO