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

Catalog Number 06C29-20

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hepatitis (1897)

Event Date 02/11/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6l27.An evaluation is in process.

Event Description

The customer observed falsely elevated igg antibody to (b)(6) a virus results while using architect havab-igg reagents.The following data was provided.Sid (b)(6) (tested (b)(6) 2015) initial (b)(6).Due to the 2015 (b)(6) results, the patient was advised not to get vaccinated.The patient was diagnosed with (b)(6) a infection and testing on (b)(6) 2018 (no sid provided) showed (b)(6) a igm (b)(6).No additional igg values were provided.The patient presented with acute (b)(6) a infection in (b)(6) 2018.The customer indicated that the patient may not have contracted acute (b)(6) had they been vaccinated.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, labeling review, and field data review.Returns were not available.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.The architect havab-igg assay demonstrated a specificity of > 99.17% in a study testing serum and plasma specimens from randomly selected blood donors (bd) and randomly selected hospitalized patients (hp).The product package insert limitations of the procedure section includes instructions that if the igg anti-hav results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute or chronic infection.Abbott link world wide data was used to evaluate historical product field performance.The product, architect havab-g assay is retired.Patient data was analyzed and compared to an established control limit for lots in the field from february 2014 to december 2015.The evaluation indicated that the patient median result for the complaint lot was comparable to other lots in the field.No unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7712005
• MDR Text Key: 114816839
• Report Number: 3002809144-2018-00089
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2015
• Device Catalogue Number: 06C29-20
• Device Lot Number: 45106LI00
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(6); LN 03M74-01 SN (B)(6)
• Patient Outcome(s): Other
• Patient Age: 28 YR