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

Catalog Number 06368921160

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative found there was potential interference in sample.He replaced a liquid level detection board and verified the sample probe adjustments.He ran performance testing which was successful.Calibration and qc were successful.Samples from the patients were requested for investigation.This investigation is ongoing.(b)(4).

Event Description

The initial reporter received questionable anti-hcv g2 elecsys results for qc material and 10 patients from the cobas 6000 e601 module serial number (b)(4).Specific data was only provided for one patient.On 13-jul-2020, result from the abbott architect was "reactive".On 14-jul-2020, the result by pcr was "not-detected".On 16-jul-2020, the result from the cobas e601 were 0.045 and 0.045 coi (non-reactive).The questionable results were reported outside of the laboratory.

Manufacturer Narrative

Samples from the patient was received for investigation and the customer's non-reactive anti-hcv results were reproduced.The innolia hcv score result was also found negative for both samples.Therefore, the non-reactive result was considered to be correct.A general reagent issue was excluded.

• Brand Name: ELECSYS ANTIHCV II IMMUNOASSAY
• 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: 10362007
• MDR Text Key: 201579486
• Report Number: 1823260-2020-01890
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 06368921160
• Device Lot Number: 45793301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59