MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTIHCV II IMMUNOASSAY; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number	07026889190
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 complained of (b)(6) elecsys anti-hcv ii immunoassay results for 1 patient sample on a cobas 8000 e 602 module and a cobas 8000 e 801 module.The e 602 module serial number was (b)(6) and the e 801 module serial number was (b)(6).The initial anti-hcv ii result was (b)(6) on the e 602 module with reagent lot number 31063600.The patient questioned the result.On (b)(6) 2018, the repeat anti-hcv ii result was (b)(6) on the e 801 module with reagent lot number 31072500.The customer then sent the sample to a different laboratory and the anti-hcv result was (b)(6) with the immunoblot method.The specific date of the immunoblot result was not provided.There were erroneous results reported outside of the laboratory.There was no allegation of an adverse event.This medwatch will cover anti-hcv ii reagent lot number 31063600.Refer to medwatch with patient identifier (b)(6) for information on anti-hcv ii reagent lot number 31072500.
Additional Manufacturer Narrative
Sample from the patient was submitted for investigation and further testing by the fujirebio innolia hcv score confirmed the negative result.The negative elecsys anti-hcv ii immunoassay result was therefore believed to be correct.

• Brand Name: ELECSYS ANTIHCV II IMMUNOASSAY
• Common Device Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7845478
• Report Number: 1823260-2018-02991
• Device Sequence Number: 11129955
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P140021
• 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): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07026889190
• Device Lot Number: 31063600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR