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	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received questionable results for one patient sample from the cobas 8000 core unit.The initial elecsys tsh assay result was 0.042 miu/ml and the repeat results were 0.044 miu/ml and 0.864 miu/ml.The initial elecsys ft4 ii assay result was 0.093 ng/dl and the repeat results were 0.058 ng/dl and 1.18 ng/dl.The erroneous results were reported outside of the laboratory.The second repeat results were believed to be correct.There was no allegation of an adverse event.The tsh reagent lot number was 307192 with an expiration date of 30-sep-2018.The ft4 reagent lot number was 288197.The expiration date was requested but was not provided.
Additional Manufacturer Narrative
The provided qc and calibration data is acceptable.The alarm trace contains multiple abnormal sample absorption alarms which indicate a pre-analytical preparation issue.Based on the qc and calibration data, a general reagent issue can be excluded.The investigation did 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: 7888596
• Report Number: 1823260-2018-03185
• Device Sequence Number: 11228077
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 4015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 11/01/2018

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: 05641446001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR