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

Model Number	6L27-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002809144-2022-00048
• Device Sequence Number: 14773638
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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.
• Patient Sex: Unknown