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

Model Number	E801
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter complained of a discrepant negative result for 1 patient sample tested for elecsys toxo igg (toxo igg) on a cobas e801 module.The initial result was 0.51 ui/ml (negative).On (b)(6) 2021 a new sample was obtained and the result was 9.26 ui/ml (positive).On (b)(6) 2021 the original sample was repeated with a result of 8.9 ui/ml (positive).The negative result was not reported outside of the laboratory.The toxo igg reagent lot number was 517479.The expiration date was not provided.
Additional Manufacturer Narrative
Based on the available information, 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: 12183238
• Report Number: 1823260-2021-02067
• Device Sequence Number: 11143313
• Product Code: JJE
• UDI-Device Identifier: 07613336158562
• UDI-Public: 07613336158562
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/19/2021

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: E801
• Device Catalogue Number: 08459606001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 09/28/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/20/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1