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	04/19/2022
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 false reactive architect havab-g result for a patient sample while running on the architect i1000sr analyzer.The negative control was running higher than the peer group but was still in range.The customer pulled patient samples to repeat that had values close to the cutoff and had one discrepant result that went from reactive to nonreactive.The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): sid (b)(6) tested on (b)(6) 2022.Initial result: 1.13 s/co (reactive on lot 29510be00); repeat on new lot 35328be00: 0.94 s/co (nonreactive) there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive architect havab-g results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search by lot indicates that lot 29510be00 performs as expected for this product.A review of tracking and trending did not identify any related trends.The overall performance of architect havab-g reagents in the field was reviewed using data gathered from customers worldwide.Standard deviation to cutoff for the negative population and median values (for the negative population) for the complaint lot are within the established limits and comparable to the historical reagent lot performance.As review of applicable field data suggests that the performance is acceptable, file kit testing is not required.The device history record was reviewed and did not identify any non-conformances or deviations associated with the reagent lot 29510be00 and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect havab-g reagent lot 29510be00 was 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 ; EI N39 E932 ; 433331157
• MDR Report Key: 15026460
• Report Number: 3002809144-2022-00245
• Device Sequence Number: 14598229
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 07/13/2022
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 29510BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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 I1000SR MOD, 01L86-01, (B)(6) ; ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Sex: Unknown