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 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of an erroneous low result for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module.The erroneous result was not reported outside of the laboratory.The initial gluc3 result was 53.7 mg/dl.The sample was repeated twice with results of 91 mg/dl and 87.7 mg/dl.The result of 91 mg/dl was believed to be correct and reported outside of the laboratory.There was no allegation that an adverse event occurred.The gluc3 reagent lot number was 236290 with an expiration date of 07/31/2018.The customer stated quality controls (qc) were within specification prior to the event.Monthly maintenance was last performed on 07/24/2017.Based on the reaction monitor provided, a pipetting error may have occurred.Calibration data appear to be ok.The customer uses a centrifugation time of 6 minutes which is likely too low.The alarm trace shows frequent "detergent < warning level" alarms which indicate the detergent bottle needs to be changed.A review of the precision check data indicates potential issues with sample pipetting and reagent pipetting.

Manufacturer Narrative

The field service engineer (fse) visited the customer site a replaced the syringe mechanism.Precision testing was repeated afterwards and results were ok.

• 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: 6833697
• MDR Text Key: 84321773
• Report Number: 1823260-2017-01872
• 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,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• 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: 08/11/2017
• 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