MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Model Number 03R6501

Device Problem False Negative Result (1225)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further patient information was provided.

Event Description

The customer obtained a (b)(6) result while using the alinity i processing module.The patient was a (b)(6) male undergoing chemotherapy for a malignant tumor.The sample generated non-reactive results of (b)(6) s/co on the alinity and positive results with the elisa and tppa assays.The customer further indicated (b)(6) 2021 the patient's sample was negative on roche luminescence 0.068 coi.On (b)(6) 2021 the patient's sample generated negative results on architect 0.26 s/co, rpr and elisa.No impact to patient management was reported.

Manufacturer Narrative

H6 health effect impact code: f26.H6 component code: g03001.D8 was this device serviced by a third party? no.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing of the complaint lot.Trending review determined identified no trends associated with the complaint issue.Device history record review for the complaint lot did not identify any non-conformances or deviations.A retained reagent kit of the complaint lot was tested in a sensitivity setup.All specifications were met and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Based on our investigation, no systemic issue or deficiency with the alinity i syphilis tp assay was identified.After further evaluation, the suspect medical device was changed from alinity i processing module, list number 03r65-01, serial (b)(6) throughout section d of this report to alinity i syphilis, list number 07p60-77 and lot 15228be01 from the same manufacturing site.Additionally section d11 was changed from the alinity i syphilis reagent to the alinity i processing module.

Manufacturer Narrative

The incorrect component code was entered in h6.The correct component code is g01003.No other corrections or updates are required.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ALINITY I SYPHILIS TP REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11204965
• MDR Text Key: 243602352
• Report Number: 3002809144-2021-00042
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00380740137366
• UDI-Public: 00380740137366
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2021

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: 03/16/2021
• Device Model Number: 03R6501
• Device Catalogue Number: 07P60-77
• Device Lot Number: 15228BE01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 03/10/2021; 05/18/2021
• Supplement Dates FDA Received: 03/09/2021; 03/10/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIN I SYPHILS 1200T CN, 07P60-77, (B)(6); ALNTY I PROCESSING MODU, 03R65-01,; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 59 YR