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	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received questionable results for an unspecified number of patient samples tested for trsf2 tina-quant transferrin ver.2 on a cobas 8000 core unit.The customer states that the issue occurs intermittently.Initial results from affected samples will be very low and upon repeat, the result is normal.The issue occurs with 2 to 3 patient samples every day.The customer provided data for two patient samples with erroneous trsf2 results.The erroneous results from these samples were not reported outside of the laboratory.The first sample initially resulted with a trsf2 value of 2 mg/dl, which repeated as 262 mg/dl.The second sample initially resulted with a trsf2 value of 1 mg/dl, which repeated as 159 mg/dl.No adverse events were alleged to have occurred with the patients.The trsf2 reagent lot number was 33436301, with an expiration date of 29-feb-2020.The customer found the saline on board the analyzer was out of stability.Calibration and controls were ok.The customer moved the assay to the other reagent disk of the analyzer.Since this action, the customer did not have any further issues.
Additional Manufacturer Narrative
No problems were seen upon review of the calibration data.The provided quality control data showed good precision.The reaction kinetic data of the affected sample results showed no reaction occurred.The field service engineer replaced a wash station tube and found leakage in the wash station.After changing the tubing, the customer did not have any further issues.The investigation determined that the service actions resolved the issue.

• 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: 7777885
• Report Number: 1823260-2018-02709
• Device Sequence Number: 1280266
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/03/2018

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: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1