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

Model Number C501

Device Problem High Test Results (2457)

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

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of an erroneous high result for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module.The initial gluc3 result was 153.6 mg/dl.This result was reported outside of the laboratory where the doctor questioned it.On (b)(6) 2017 the sample was repeated and the result was 113.4 mg/dl.On (b)(6) 2017 the sample was repeated again and the result was 108.0 mg/dl.There was no allegation that an adverse event occurred.The gluc3 reagent lot number was 254446 with an expiration date of 30-sep-2018.Calibration and quality controls (qc) were acceptable.No issues were identified during a review of alarm trace data.Based on the reaction monitor provided, the initial high result showed a general higher absorbance.The high result may have been due to more sample pipetted into the reaction cell.Based on the precision data provided, there may be issues with the reagent pipettor or the rinse units.A specific root cause was not identified.Since calibration and qc data was acceptable, a general reagent issue is not suspected.Based on the information available, the most likely root cause is related to pre-analytics or deposits on the sample probe.Too much sample could have been transferred due to fibrin strands which can be caused by improper primary tube handling or coagulation/centrifugation issues related to the 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: 6885792
• MDR Text Key: 88232088
• Report Number: 1823260-2017-02043
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• 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: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1