MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-HAV; HEPATITIS A TEST

Catalog Number 07026757190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they have observed non-linear dilution behavior for an unspecified number of patient samples tested for elecsys anti-hav 2nd gen.Assay (anti-hav) on a cobas 8000 e 801 module (e801).The customer routinely uses an initial dilution ratio of 1:2 in case values are above the measuring range.The customer stated that for example, a sample will have a first measurement result of (b )(6).When the sample is diluted 1:2 and tested, the value will be (b)(6).The customer stated that they had 10 samples with non-linear dilution behavior one day.The customer did not believe that all 10 of these patients had a fresh infection with interfering igm molecules.The customer provided data for 5 specific patient samples that had erroneous (b)(6) results.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.Refer to the attachment for all patient data.Each sample was tested without dilution and were repeated after being diluted 1:10 and 1:20.The observations of the customer were confirmed by repeating the same samples at a different site.No adverse events were alleged to have occurred with these patients.The e801 analyzer serial number is (b)(4).Patient samples were provided for investigation and the customer's observation could be duplicated.

Manufacturer Narrative

Medwatch field "date rec'd by mfr" has been updated.Please note, in the previous supplemental report we mistakenly indicated the initial mdr was filed late, outside the 30 day window.This was a mistake.The initial and all supplemental mdrs were filed within their respective 30-day windows.

Manufacturer Narrative

It has been confirmed that the patient age of (b)(6) and sex of female apply to patient sample 1.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• Brand Name: ANTI-HAV
• Type of Device: HEPATITIS A TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7329452
• MDR Text Key: 102217122
• Report Number: 1823260-2018-00753
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• PMA/PMN Number: K100903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07026757190
• Device Lot Number: 283252
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR