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 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous glucose results for 1 patient sample tested on a cobas 6000 c (501) module.The erroneous results were not reported outside of the laboratory.The initial glucose result from the c501 module was 55.8 (unit of measure not provided).The sample was repeated on the c501 module and the result was 79.8.The sample was repeated on a gasometer device and the result was 88.0 (unit of measure not provided).The result of 88.0 was reported outside of the laboratory.There was no allegation that an adverse event occurred.The glucose reagent lot number and expiration date were not provided.The field service engineer (fse) visited the customer site and found a fold in the sample syringe tubing.The fse fixed this but the issue was not resolved.The syringe was removed from the module where the gears were checked.A screw was loose where the plunger was attached to the syringe.The screw was tightened and the plunger was fixed.Afterwards, glucose reproducibility tests were performed with a patient sample and quality control material and the results were acceptable.The root cause of the issue was determined to be the loose screw the fse identified.

• 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: 6797563
• MDR Text Key: 86135745
• Report Number: 1823260-2017-01714
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• 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: 07/26/2017
• 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