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

Catalog Number 07P60-77

Device Problem False Negative Result (1225)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = sample id (b)(6), sample id (b)(6), and sample id (b)(6).All available patient information was included.Additional patient details are not available.Phone complete entry: (b)(6).This report is being filed on an international product, list number 07p60-77, that has a similar product distributed in the us, list number 07p60-31.

Event Description

The customer observed (b)(6) alinity i syphilis tp results for three patients.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) initial result was (b)(6), when tested with the colloidal gold method and tppa it was (b)(6).Sample id (b)(6) result was (b)(6), when tested with the colloidal gold method and tppa it was (b)(6).Sample id (b)(6) result was (b)(6), when tested with the colloidal gold method and tppa it was (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a false nonreactive alinity i syphilis tp result 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 testing of retained reagent kits of the complaint lot number.Trending review determined no related trend for the issue for the product.Sensitivity testing was performed using an in-house retained kit of lot numbers 28076be01 and 30365be01, stored at the recommended storage condition.All specifications were met, and no false reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Device history record review did not identify any non-conformances or deviations with the likely cause lots and complaint issue.Manufacturing documentation for the likely cause lots were reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i syphilis tp, lot numbers 28076be01 and 30365be01, was identified.

Manufacturer Narrative

Returned patient samples were able to be tested, on (b)(6) 2022 as part of the complaint investigation, with the following results: sample id tp1 alinity i syphilis tp: 1.07 s/co (reactive) recomline treponema igm: negative recomline treponema igg: negative sample id tp2 alinity i syphilis tp: 0.94 s/co (non-reactive) recomline treponema igm: negative recomline treponema igg: borderline (tp453: ++, tp17: +/-, tp257: +/-) sample id tp3 alinity i syphilis tp: 1.32 s/co (reactive) recomline treponema igm: negative recomline treponema igg: borderline (tma: +, tp47: +/-, tp15: +/-) based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i syphilis tp, lot numbers 28076be01 and 30365be01, was identified.

Manufacturer Narrative

Section d9 - date returned to mfg date was removed as it was inadvertently added.

• 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
• 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: 13846627
• MDR Text Key: 289485151
• Report Number: 3002809144-2022-00101
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153730
• 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,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2022
• Device Catalogue Number: 07P60-77
• Device Lot Number: 28076BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIN I SYPHILS 1200T CN, 07P60-77, (B)(6).; ALIN I SYPHILS 1200T CN, 07P60-77, (B)(6).; ALIN I SYPHILS 1200T CN, 07P60-77, (B)(6).; ALIN I SYPHILS 1200T CN, 07P60-77,(B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).