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

Model Number	COBAS 8000 CORE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer complained of an erroneous high result for 1 patient sample tested for elecsys cea assay (cea) on a cobas 8000 core unit.The initial cea result was 221.30 ng/ml.This result was reported outside of the laboratory.On (b)(6) 2018 a new sample was obtained and the cea result was 1.56 ng/ml.The original sample was repeated and the result was 1.56 ng/ml.There was no allegation that an adverse event occurred.The cea reagent lot number was 28657406.The expiration date was not provided.The customer stated the initial sample was lipemic.The customer is wondering if this affected the initial high result.
Additional Manufacturer Narrative
The alarm trace data from the day of the event show multiple messages related to sample quality.The sample in question was visibly lipemic.Calibration signals were within the acceptable ranges.No qc data was available from the day of the event.Analyzer performance testing data was within specification.The investigation was unable to determine a definitive root cause.
Additional Manufacturer Narrative
It was clarified that the new sample was obtained on (b)(6) 2018 instead of 07-jul-2018 and the cea result was actually 1.01 ng/ml.The original sample from (b)(6) 2018 was repeated on (b)(6) 2018 with a result of 1.56 ng/ml.The result of 1.56 ng/ml is believed to be correct.

• 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: 7703627
• Report Number: 1823260-2018-02401
• Device Sequence Number: 1018677
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• 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): 08/15/2018

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: 05641446001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/07/2018
• Supplement Date Received by Manufacturer: 07/07/2018; 07/07/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 07/25/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1