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 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter received a questionable non-reactive elecsys anti-hcv ii immunoassay result on one patient from a cobas 6000 e 601 module, serial number (b)(4).The questionable anti-hcv result was not reported outside the laboratory.The patient originally tested (b)(6) at the blood bank laboratory with an unknown method.The patient's anti-hcv result from the e 601 was (b)(6).The questionable anti-hcv result was not reported outside the laboratory.The customer performed further testing and the repeat result on the liaison was (b)(6) on the architect.

Manufacturer Narrative

The patient's sample was provided for investigation.The investigation confirmed the customer's elecsys result.The sample was also tested with the innolia hcv score method and the result was negative, confirming the patient's sample was a true negative.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 9922283
• MDR Text Key: 221486294
• Report Number: 1823260-2020-00949
• 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: 05/29/2020

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: 07/31/2020
• Device Catalogue Number: 06368921190
• Device Lot Number: 445854
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR