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

Catalog Number 08P26-22

Device Problem High Test Results (2457)

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.This event was previously submitted under an additional suspect medical device in manufacter's report 3002809144-2019-00266.

Event Description

The customer observed (b)(6) alinity havab igg results.The following data was provided: (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

A search for similar complaints for the alinity i havab igg, lot number 92507li00 & 93196li00 (the two lots in use by the customer) did not identify additional complaints and no trends were identified for the product issue.Return testing was not completed as returns were not available.92507li00 was expired, therefore, specificity testing was performed using a retained kit of 93196li00.To evaluate reagent specificity, 12 replicates of negative control were tested.All control values met specifications.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue and/or product deficiency was identified.

• 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: 8933482
• MDR Text Key: 159177874
• Report Number: 3002809144-2019-00531
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2019
• Device Catalogue Number: 08P26-22
• Device Lot Number: 92507LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I ANALYZER, LN 03R65-01; ALINITY I ANALYZER, LN 03R65-01; SN (B)(4); SN (B)(4)