MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E801
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of a questionable elecsys ferritin result from 1 patient sample tested on a cobas 8000 e 801 module.The initial ferritin result was 0.2 ng/ml.The same patient sample was tested on another cobas e801 and a ferritin result of 54 ng/ml was obtained.The erroneous result was not reported outside of the laboratory.The ferritin result of 54 ng/ml was determined to be plausible.There was no allegation of an adverse event.The ferritin reagent lot was 30832700 with an expiration date of 31-jul-2019.The field engineering specialist determined the error was caused by the valves on top of the reagent probe syringes.The valves would get stuck from time to time causing incorrect reagent pipetting.He replaced the affected valves and the issue has been considered resolved.The investigation is currently ongoing.
Additional Manufacturer Narrative
The alarm trace indicated on the date of the event that there were a number of short samples measured and a number of sample clots were identified.This is consistent with poor sample quality.The investigation did not identify a product problem.  the cause of the event could not be determined. .

• Brand Name: COBAS 8000 E 801 MODULE
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7991347
• Report Number: 1823260-2018-03778
• Device Sequence Number: 11183092
• Product Code: JJE
• UDI-Device Identifier: 04015630939688
• UDI-Public: 4015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K060373
• 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): 06/24/2019

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 Expiration Date: 07/31/2019
• Device Model Number: E801
• Device Catalogue Number: 07682913001
• Device Lot Number: 30832700
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1