MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer complained of discrepant results for 1 patient sample tested for vitamin d total on a cobas 8000 core unit.The date of event is either (b)(6) 2018.Clarification on the correct date has been requested.The initial vitamin d total result was 3.34 ng/ml.The sample was repeated and the result was 6.77 ng/ml.A new sample was obtained and the vitamin d total result was 16.20 ng/ml.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The vitamin d total reagent lot number was 34167100 with an expiration date of 30-jun-2019.
Additional Manufacturer Narrative
The date of event was confirmed to be (b)(6) 2018.
Additional Manufacturer Narrative
A general reagent issue can be excluded.Based on the pre-analytical information provided the event is consistent with a pre-analytical handling issue.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 8000 CORE UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7809508
• Report Number: 1823260-2018-02839
• Device Sequence Number: 13949780
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 4015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100853
• 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,Followup
• Report Date (Section B): 10/15/2018

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: COBAS 8000 CORE
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018; 08/07/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 08/27/2018; 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1