MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G; IGG ANTI-HAV

Model Number 6L27-25

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier multiple = (b)(6).There was no additional patient information provided by the customer.

Event Description

While running a comparative study between lots, the customer reported (b)(6) architect havab-g assay results for four patients on the current lot 12026be00, which was used for individual patient management.The customer provided: (b)(6) initial = (b)(6); (b)(6) initial = (b)(6); (b)(6) initial = (b)(6); (b)(6) initial = (b)(6).(ranges: (b)(6)).There was no impact to patient management reported.

Manufacturer Narrative

The evaluation of the customer issue 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 field data review.Trending review determined no trend for this issue for the product.Device history record review did not identify any non-conformances or deviations associated with the customers issue.The overall performance of architect havab-g reagents in the field was reviewed and found to be acceptable.Based on all available information no product deficiency was identified.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10093083
• MDR Text Key: 228393580
• Report Number: 3002809144-2020-00415
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 12026BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR; ARCHITECT I2000SR,; LN 03M74-02 , SN (B)(6); LN 03M74-02, SN (B)(6)