MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received a discrepant gluc3 glucose hk result for a patient sample on the cobas 6000 c (501) module.The initial glucose result was 768 mg/dl with a data flag.The sample was automatically rerun on the c501 module with a glucose result of 125 mg/dl and was reported outside the laboratory.The result was questioned by the emergency room staff.A different sample from the same patient was run with a glucose result of 700 mg/dl and was deemed to be correct.Repeat testing was performed on the same c501 module.There was no adverse event.The glucose reagent lot number was 25244601 with an expiration date of 30-sep-2018.The field service engineer (fse) could not determine a root cause.The fse checked the adjustments of the c501 module and ran precision that were within specifications.The customer ran calibration and quality control that were within specifications.

Manufacturer Narrative

Further investigation was not able to determine a specific root cause.The possible root cause may be pre-analytics and sample quality.

• Brand Name: COBAS 6000 C501 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: 6995839
• MDR Text Key: 91928619
• Report Number: 1823260-2017-02505
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• 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