MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I TOXO IGG REAGENT KIT; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Catalog Number 07P45-32

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i toxo igg results for three patients compared to results on another instrument.The following data was provided: sid (b)(6): 1st pass: ai23467 2.064 iu/ml, 2nd pass: ai23450 0.401 iu/ml.Sid (b)(6): 1st pass: ai23450 8.2558 iu/ml, 2nd passage: ai23450 0.266 iu/ml.Sid (b)(6): 1st visit: ai 23467 10.633 iu/ml, 2nd pass: ai23450 0.132 iu/ml.No impact to patient management was reported.

Manufacturer Narrative

Complete information from patient identifier: multiple: sid: (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Note: as there were more initial reactive results, that repeated non-reactive obtained after instrument troubleshooting was performed the issue does not seem to be related to the instrument.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Return testing was not performed as returns were not available.Device history record review was performed on lot(s) 44254be00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the product for the issue.In-house testing of a retained reagent kit of the complaint lots was performed.All specifications were met, and no false reactive results were obtained, showing that the lots generate the expected results.Labeling review concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the alinity i toxo igg assay was identified.During the product evaluation, it was determined that the likely cause product is the alinity i toxo igg reagent kit.The likely cause product has been changed again, from the alinity i processing module back to the alinity i toxo igg reagent kit on 27jan2023.All further information will be provided under this product.Cross reference mdr number (b)(4).

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from alinity i toxo igg reagent kit, list number 07p45-32, and manufacturing site in section d of this report (abbott gmbh) to alinity i processing module, list number 03r65-01, and manufacturing site of new suspect device (abbott laboratories).Mdr number 3016438761-2023-00043-00 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ALINITY I TOXO IGG REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15934684
• MDR Text Key: 308089955
• Report Number: 3002809144-2022-00423
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K210596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: 07P45-32
• Device Lot Number: 44254BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/25/2023; 01/27/2023
• Supplement Dates FDA Received: 01/26/2023; 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6). ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).