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 08/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they had been having intermittent issues with low values for an unspecified number of patient samples tested for ise indirect k for gen.2 (potassium) on a cobas 6000 c (501) module - c501.The customer provided data for two patient samples that had questionable initial potassium results.Of these, one had an erroneous potassium result that was reported outside of the laboratory.The sample was repeated and the repeat result was believed to be correct.The sample initially resulted as 3.3 mmol/l and repeated as 4.0 mmol/l.The patient was not adversely affected.The potassium electrode lot number and expiration date were asked for, but not provided.The field service engineer determined there was a fluidic failure of the analyzer as the vacuum pressure was too low.The vacuum line at the vacuum vessel was not attached.He replaced and re-attached the vacuum line, replaced vacuum diaphragms.He replaced the ise sipper, sipper cover, and spring.He verified the fluidics dispense and probe alignment.A mechanism check was performed and this passed.The customer ran calibration and quality controls.Controls were near mean values.The instrument was determined to be performing within specifications.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.

• 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: 6868054
• MDR Text Key: 87308098
• Report Number: 1823260-2017-01998
• Device Sequence Number: 0
• Product Code: CEM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2017
• 2 Devices were Involved in the Event: 1 2

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: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 08/27/2017
• Supplement Dates FDA Received: 09/20/2017
• 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