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

Catalog Number 04854977190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).The event occurred in: (b)(6).

Event Description

The customer received questionable elecsys anti-hav assay gen 2 results for one patient sample upon dilution.The anti-hav result undiluted was (b)(6).The siemens centaur result for a-hav igg was >(b)(6).It was not known if the erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The cobas e 411 immunoassay analyzer serial number was (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

Control samples were tested.The recovery of the samples was within the specified range.A general reagent issue can be excluded.The investigation is ongoing.

Manufacturer Narrative

The presence of human anti-mouse antibodies (hama) in the sample were confirmed.This limitation is covered in product labeling.The complained sample contains high amounts of hama and even higher amounts of specific analyte, which is further corroborated by the observation of the customer that dilution of the complaint sample leads to detection of high titers of specific analyte.In such a scenario, the dilution leads to dilution of the hama effect while the remaining analyte is sufficient to compete with the assay antibody conjugates for binding to the antigen.Hence the higher the dilution ratio, the more likely the true analyte concentration is detected.

• 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: 7602198
• MDR Text Key: 111893178
• Report Number: 1823260-2018-01913
• 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
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 04854977190
• Device Lot Number: 303195
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR