MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV); ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number 06368921190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was not available for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant results for 1 patient tested for elecsys anti-hcv ii immunoassay (anti-hcv ii) on a cobas e 411 immunoassay analyzer.The initial result from the e411 analyzer was (b)(6).This result was reported outside of the laboratory where the physician requested repeat testing.On (b)(6) 2020 the sample was repeated on the e411 analyzer and the result was (b)(6).The customer sent the sample to an external laboratory where the result from the abbott method was (b)(6).On (b)(6) 2020 a new sample was obtained and the result from the e411 analyzer was (b)(6).This sample was also sent to an external laboratory where the result from the abbott method was (b)(6).The e411 analyzer serial number was (b)(4).

• Brand Name: ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV)
• Type of Device: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9927857
• MDR Text Key: 221487262
• Report Number: 1823260-2020-00955
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P140021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 06368921190
• Device Lot Number: 42701301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1