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 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer has been having intermittent issues with patient and quality control (qc) results for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module since (b)(6) 2017.The customer provided questionable results for 2 patient samples tested for gluc3 on (b)(6) 2017.Based on the data provided, the results for 1 patient were erroneous.The erroneous results were not reported outside of the laboratory.The initial gluc3 result from the c501 module was 14 mg/dl.The sample was repeated on an abl 800 flex analyzer and the result was 89 mg/dl.The result of 89mg/dl was believed to be correct.No adverse event occurred.The gluc3 reagent lot number was 23629001 with an expiration date of 07/31/ 2018.The field service engineer (fse) visited the customer site.The sample probe was contaminated with sample deposits on the bottom of the sample probe caused by an insufficient amount of sample in the tubes.Calibration and qc failed due to gel deposit carry over on the bottom of the sample probe.The fse cleaned and adjusted the sample probe.The results of an instrument check were within specification.The customer ran calibration and qc and the results met their specifications.

Manufacturer Narrative

During a review for this customer site, there were no similar past complaints on any like instrument for the past 12 months.Complaints regarding discrepant gluc3 results with the specific sample probe part number were reviewed and showed no abnormal trends in the past 90 days.

Manufacturer Narrative

The customer stated they are not having any further issues.

• 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: 6759468
• MDR Text Key: 81688496
• Report Number: 1823260-2017-01579
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• 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: 07/14/2017
• 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: 63 YR