MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB IGG REAGENT; ARCHITECT HAVAB-IGG

Catalog Number 06C29-27

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Age at time of event, the patients were between 30 and 50 years old, however a specific age for each patient was not provided.This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6c27.

Event Description

The customer observed multiple falsely elevated (b)(6) patient results while using the architect (b)(6) reagents.The following data was provided (s/co).Sid (b)(6) initial 1.60 ((b)(6)), repeat 1.85 ((b)(6)).Sid (b)(6) initial 1.02 ((b)(6)), repeat 0.88 ((b)(6)).Sid (b)(6) initial 1.21 ((b)(6)), repeat 1.17 ((b)(6)).Sid (b)(6) initial 3.50 ((b)(6)), no repeat provided.Sid (b)(6) initial 2.77 ((b)(6)), no repeat provided.Sid (b)(6) initial 3.29 ((b)(6)), no repeat provided.The customer stated that all the patients are healthy and were being tested for occupational health issues.No impact to patient management was reported.

Manufacturer Narrative

Additional patients were included.Device manufacturers only 10.This report is being filed on an international product, list number 6c29.The similar product distributed in the us list number was changed to 6l27 from 6c27.An evaluation is in process.

Event Description

The customer observed multiple falsely elevated igg anti-hav patient results while using the architect havab-igg reagents.The following data was provided (s/co).Sid (b)(6) initial 1.60 (reactive), repeat 1.85 (reactive).Sid (b)(6) initial 1.02 (reactive), repeat 0.88 (nonreactive).Sid (b)(6) initial 1.21 (reactive), repeat 1.17 (reactive).Sid (b)(6) initial 3.50 (reactive), no repeat provided.Sid (b)(6) initial 2.77 (reactive), no repeat provided.Sid (b)(6) initial 3.29 (reactive), no repeat provided.Sid (b)(6) initial 2.03 (reactive), no repeat provided, previous result for this patient from 2016 was 1.98 (reactive).Sid (b)(6) initial 1.99 (reactive), repeat 2.16 (reactive), previous result for this patient from 2016 was 1.6 (reactive) and elisa negative.Sid (b)(6) initial 1.73 (reactive), previous result for this patient from 2016 was 1.15 (reactive).Sid (b)(6) initial 1.98 (reactive), repeat 2.19 (reactive).The customer stated that all the patients are healthy and were being tested for occupational health issues.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, labeling review, returned specimen testing, and specificity testing.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.Four patient specimens were returned, however the product was not available for return.Specimens sid (b)(6) were tested with retained kits of the likely cause reagent lot and were also tested using other methods, including vidas anti-hav total method and biorad monolisa total anti hav plus method.The four specimens were reactive using the architect method (lots 70628li00 and 72320li00) and the biorad method.The specimens were also reactive using the vidas method, with the exception of sid (b)(6), which was borderline.The customer stated that this patient sid (b)(6) had received two doses of hav vaccine prior to the sample being drawn.Additionally, clinical specificity testing of negative control replicates was performed using retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics complaint investigation, no systematic issue was identified and no product deficiency was identified.

• Brand Name: ARCHITECT HAVAB IGG REAGENT
• Type of Device: ARCHITECT HAVAB-IGG
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6688171
• MDR Text Key: 79148545
• Report Number: 3002809144-2017-00108
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 06C29-27
• Device Lot Number: 70628LI00
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1