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

Model Number	ANTI-HAV IGM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was submitted for investigation.The customer's positive results were reproduced.The investigation is ongoing.The follow up/corrective action was the sample was requested for investigation.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.Erroneous high results were generated by a cobas e801 module.The event involved 1 patient with the high results for anti-hav igm.The patient was a male.
Additional Manufacturer Narrative
Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.Product labeling also states single false positive results can occur.

• Brand Name: ELECSYS ANTI-HAV IGM
• Common Device Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8551514
• Report Number: 1823260-2019-90101
• Device Sequence Number: 11221777
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: ANTI-HAV IGM
• Device Lot Number: 345794
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1