MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Model Number ANTI-HAV IGM

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.There were no follow up/corrective actions.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction events.(b)(6) results were generated by the cobas 6000 e601 module the events involved a total of 1 patient with the following: one (b)(6) result for elecsys anti-hav igm.The patient's age was (b)(6).The patient's weight was requested, but not provided.The patient's gender was male.The patient's race was requested, but not provided.The patient's ethnicity was requested, but not provided.

• Brand Name: ELECSYS ANTI-HAV IGM
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8281239
• MDR Text Key: 134338001
• Report Number: 1823260-2019-90052
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ANTI-HAV IGM
• Device Lot Number: 322325
• Type of Device Usage: N
• Patient Sequence Number: 1