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

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer complained of an erroneous low result for 1 patient sample tested for ureal urea/bun (ureal/bun) on a cobas 8000 core unit.The initial ureal/bun result was 0.3 mmol/l.This result was converted to a result of < 0.5 mmol/l due to a rule in the customer's middleware and released from the laboratory with no data alarm or flag.This result was questioned and the sample was repeated with a result of 6.8 mmol/l.There was no allegation that an adverse event occurred.The ureal/bun reagent lot number was 307009.The expiration date was not provided.Calibration and qc data appear to be acceptable.The customer was not having issues with any other assays.
Additional Manufacturer Narrative
General reagent and/.Or instrument issues have been excluded.The investigation was unable to determine a definitive root cause.

• 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: 7682626
• Report Number: 1823260-2018-02289
• Device Sequence Number: 1316211
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 4015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/24/2018

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: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1