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 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was requested for investigation.

Event Description

The initial reporter questioned (b)(6) results for 1 patient tested for elecsys (b)(6) immunoassay (b)(6) on a cobas 6000 e 601 module.The patient had been tested previously by another, unknown method with a (b)(6) result.The patient was initially tested by the e601 module and the (b)(6) result was (b)(6).The customer had not run qc the day of the initial (b)(6) results.The customer re-calibrated and ran qc and repeated an aliquot of the sample.The result from the e601 module was (b)(6).The roche results were reported outside of the laboratory to the patient.Another aliquot of the sample was sent to an external laboratory where the sample was tested by the abbott architect, elisa and pcr methods.The abbott and elisa results were (b)(6).The actual results were not provided.The pcr result was (b)(6).The sample was also tested by immunoblot and the result was indeterminate.

Manufacturer Narrative

The e601 module serial number was (b)(4).No sample material was submitted for investigation.Qc results were within specification.As no sample was available, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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
• MDR Report Key: 10576733
• MDR Text Key: 210627705
• Report Number: 1823260-2020-02334
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• PMA/PMN Number: P140021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 06368921190
• Device Lot Number: 47285001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1