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

Model Number 6L27-25

Device Problem False Positive Result (1227)

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

Event Date 01/23/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a (b)(6) architect havab-g result for one patient.The initial architect havab-g result was (b)(6) repeated on another instrument and the result was (b)(6) no impact to patient management was reported.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the likely cause lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed on lot number 26319be00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.In-house testing of a retained calibrator of the complaint lot was performed.All specifications were met and no false reactive results were obtained, showing that the lot generates the expected results.Labeling review concludes that the issue is adequately addressed.Based on all reviewed data, we conclude that there is no systemic issue or deficiency identified.

• Brand Name: ARCHITECT HAVAB-G 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 ; 433331157
• MDR Report Key: 13525428
• MDR Text Key: 289605156
• Report Number: 3002809144-2022-00048
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113704
• 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: 04/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 26319BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC HAVAB-G CAL, 06L27-01, 26319BE00.; ARC HAVAB-G CAL, 06L27-01, 26319BE00.; ARC I1000SR MOD, 01L86-01, I1SR60651.; ARC I1000SR MOD, 01L86-01, I1SR60651.