MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number 06C30-27

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

The customer reported falsely nonreactive architect havab-igm results on two patients.Results provided: (b)(6) = 0.65 / 0.55 s/co.Repeated on vidas: positive, hav rna detected, oral fluid sample: positive.(b)(6) 2022 sid (b)(6) = 0.05 s/co, repeated on roche cobas positive = 14.10, hav oral fluid sample: positive.Interpretation: nonreactive < 0.80 s/co grayzone 0.80 -1.21 s/co reactive >=1.21 s/co.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Patient identifier sids: (b)(6).This report is being filed on an international product, list number 6c30 that has a similar product distributed in the us, list number 6l21.

Manufacturer Narrative

The complaint investigation for false non-reactive results tested with the architect havab igm assay lot 30613be00 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing.Trending review determined no trends for the issue for the product listed.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.In-house testing of a retained reagent kit of the complaint lot determined that the sensitivity performance is not negatively impacted.A review of the product labeling concluded that the issue is sufficiently addressed.Based on our investigation, no systemic issue or deficiency with the architect havab igm reagent lots 30613be00 was identified in the complaint.

• Brand Name: ARCHITECT HAVAB-M REAGENT KIT
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14889429
• MDR Text Key: 300589076
• Report Number: 3002809144-2022-00229
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2022
• Device Catalogue Number: 06C30-27
• Device Lot Number: 30613BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, ISR05046; ARC I2SR REFURB-SEKAT, 03M74-97, ISR05046