MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY I HAVAB-IGG; IGG ANTI-HAV

Catalog Number 08P26-22

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, alinity havab igg, list 8p26, that has a similar product distributed in the us, architect havab-g, list number 6l27.Sid's: (b)(6).

Event Description

The customer reported (b)(6) alinity i havab igg results on four patients.Example results provided: sid (b)(6) = (b)(6).Other (b)(6) results were generated on sids (b)(6).No impact to patient management was reported.

Manufacturer Narrative

Suspect medical device catalog# edited from 08p26-32 to 08p26-22 a review of tickets was performed for reagent lot number 93189li00.The ticket search determined that there is normal complaint activity for this lot number.Return testing was not completed as returns were not available.Specificity testing was performed with a retained kit of lot 93189li00and all control values met specifications and no false reactive results were obtained confirming that this lot is meeting the alinity product requirements.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i havab igg assay, lot 93189li00.

• Brand Name: ALINITY I HAVAB-IGG
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8911495
• MDR Text Key: 158975688
• Report Number: 3002809144-2019-00517
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2019
• Device Catalogue Number: 08P26-22
• Device Lot Number: 93189LI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I ANALYZER LIST 03R65-01; ALINITY I ANALYZER LIST 03R65-01; SERIAL (B)(4); SERIAL (B)(4)