MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer stated that they received an erroneous result for one patient sample tested for ise indirect k for gen.2 on a cobas 6000 c (501) module.The customer also complained of a difference in the serum index values of the sample when repeated.The complained sample is lipemic.The sample initially resulted with a k value of 5.50 mmol/l and this value was reported outside of the laboratory.The sample was repeated, resulting with a k value of 3.99 mmol/l.No adverse events were alleged to have occurred with the patient.The k electrode lot number and expiration date were asked for, but not provided.Calibration and controls are within specifications.
Additional Manufacturer Narrative
The customer has had no further erroneous results.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 6000 C (501) MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7888820
• Report Number: 1823260-2018-03191
• Device Sequence Number: 19454978
• Product Code: JJE
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1