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

Catalog Number 04745914001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Reported that they received erroneous results for one patient sample tested for ion selective electrode (ise) sodium and ise chloride.The sample initially resulted as 95 mmol/l for ise sodium and 127.5 mmol/l for ise chloride.The initial results were reported outside of the laboratory as 95 mmol/l for ise sodium and 128 mmol/l for ise chloride.The sample was repeated and resulted as 128 mmol/l for ise sodium and 86.7 mmol/l for ise chloride.The sample was repeated a second time and resulted as 126 mmol/l for ise sodium and 85.6 mmol/l for ise chloride.The sample was recentrifuged and repeated a third time and resulted as 127 mmol/l for ise sodium and 85.5 mmol/l for ise chloride.The patient was not adversely affected.The ise sodium and ise chloride electrode lot numbers and expiration dates were asked for, but not provided.The customer performed a precision check for ise sodium and ise chloride; the results were ok.A specific root cause could not be determined based on the provided information.The information suggests that there was a disturbance in the potassium chloride sipper flow path.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: COBAS 6000 C501 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312- 8504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4843976
• MDR Text Key: 5941786
• Report Number: 1823260-2015-03620
• Device Sequence Number: 0
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2015

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 Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/15/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 080 YR