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

Catalog Number	06L27-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false reactive architect havab-g result for one patient.The customer stated there has been an increase in positivity rates when switching to this lot of reagent.The following example was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): initial result, with one tube from the patient on 13dec23, was 0.51, repeat, with a secondary tube from the patient, was 1.04 s/co.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for false reactive architect havab igg results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Specificity testing was performed using in-house retained kits of the same reagent/calibrator/control combination as used by the customer, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect havab igg reagent, lot number 54031be00, or architect havab-g calibrator, lot number 51505be00, was identified.
Event or Problem Description
The customer observed a false reactive architect havab-g result for one patient.The customer stated there has been an increase in positivity rates when switching to this lot of reagent.The following example was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): initial result, with one tube from the patient on (b)(6)2023, was 0.51, repeat, with a secondary tube from the patient, was 1.04 s/co.There was no impact to patient management reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18833292
• Report Number: 3002809144-2024-00056
• Device Sequence Number: 7439442
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/19/2024

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: 07/05/2024
• Device Catalogue Number: 06L27-25
• Device Lot Number: 54031BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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, 51505BE00; ARC HAVAB-G CAL, 06L27-01, 51505BE00; ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown