MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY S CHAGAS

Catalog Number 06P08-45

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 submitted on an international product, alinity chagas ln 06p08-45, which has a similar product in the us, ln 06p08-50.

Event Description

The customer observed an increase in falsely elevated chagas results on the alinity s analyzer.The following data was provided: sid (b)(6) initial 6.364, repeat 2.428.Sid (b)(6) initial 1.358, repeat 1.362.Sid (b)(6) initial 0.928, repeat 1.162.The samples were confirmed negative on another analyzer: sid (b)(6) initial 0.013, repeats 0.013, 0.03.Sid (b)(6) initial 0.019, repeats 0.027, 0.06.Sid (b)(6) initial 0.028, repeats 0.029, 0.04.There was no impact to patient management reported.

Manufacturer Narrative

An investigation was performed and identified a deficiency for alinity s chagas, list number 06p08-45, lot number 01166be00.An increase in complaint activity resulted in identifying a product deficiency of certain lots of alinity s chagas.However, the investigation determined that the impacted lots were not distributed in the us, and therefore no further action in the us is warranted.

• Brand Name: ALINITY S CHAGAS
• Type of Device: CHAGAS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9437641
• MDR Text Key: 218645122
• Report Number: 3002809144-2019-01044
• Device Sequence Number: 1
• Product Code: MIU
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: 06P08-45
• Device Lot Number: 01166BE00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY S ANALYZER; ALINITY S ANALYZER; LN 06P16-01 SN (B)(4); LN 06P16-01 SN (B)(4)