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 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer initially stated that they were getting questionable results for a total of 6 patient samples tested for nh3l ammonia (nh3) on a cobas 6000 c (501) module - c501.Of these 5 samples, 4 had erroneous results.The first sample had an erroneous initial result that was reported outside of the laboratory.It was not clear if the second, third, and fourth samples had any erroneous results that were reported outside of the laboratory.A clarification has been requested.The first sample initially resulted as 69.7 ug/dl and this value was reported outside of the laboratory.The sample was repeated as the patient had a previous value 99.9 ug/dl on (b)(6) 2017.The repeat result of the sample was 88.5 ug/dl.The sample was repeated a second time, resulting as 160.9 ug/dl.The sample was also repeated on a cobas 8000 series analyzer, resulting as 184.8 ug/dl.The second sample initially resulted as 48.6 ug/dl on (b)(6) 2017.The sample was repeated on a cobas 8000 series analyzer, resulting as 82.6 ug/dl on (b)(6) 2017.The third sample initially resulted as 50.7 ug/dl on (b)(6) 2017.The sample was repeated on a cobas 8000 series analyzer, resulting as 78.0 ug/dl on (b)(6) 2017.No adverse events were alleged to have occurred with these patients.The nh3 reagent lot number was 207830.The reagent expiration date was asked for, but not provided.The field service engineer cleaned the analyzer with bleach, changed the gear pump head, and changed a manometer.On (b)(6) 2017, the customer stated that they received an erroneous nh3 result for the fourth patient sample.The sample initially resulted as 98.7 ug/dl and repeated as 119.2 ug/dl.The sample was also repeated on a cobas 8000 series analyzer, resulting as 134.9 ug/dl.

Manufacturer Narrative

On (b)(6) 2017, the first patient sample had a ggt result of 2252.No units of measure were provided.A reagent and hardware issue can be excluded since control recovery is ok and the calibration was successful prior to and after the event.The root cause of the event is incorrect sample preparation.Labeling instructs the customer that ammonia concentrations can increase in vitro due to breakdown of nitrogen-containing plasma components.One known source of ammonia formation at storage higher than -38 °c is an increased g-glutamyltransferase activity leading to decomposition of glutamine.

• 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: 6567290
• MDR Text Key: 75178707
• Report Number: 1823260-2017-01006
• Device Sequence Number: 0
• Product Code: JIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2017
• 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