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

Catalog Number 07P60-74

Device Problem False Negative Result (1225)

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

Event Date 02/13/2022

Event Type  malfunction  

Event Description

The customer observed a (b)(6) alinity i syphilis tp result for a (b)(6) male patient that was questioned by the physician.The following data was provided: (b)(6) 2022 sid (b)(6) initial result = (b)(6), repeat = (b)(6)), autobio platform = (b)(6)) additional laboratory data was provided: hbsag = 0.00 iu/ml anti-hbs = 0.33 miu/ml hbeag = (b)(6)anti-hbe = (b)(6) anti-hbc = (b)(6) anti-hcv = (b)(6) the patient is (b)(6).No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 07p60-74 has a similar product distributed in the us, list number 07p60-21/-31.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i syphilis tp results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review and in-house testing.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any nonconformances or deviations associated with the likely lot number 28077be01 and complaint issue.In-house sensitivity testing was completed with complaint lot number 28077be00 (which contains the same bulk material as lot number 28077be01.All specifications were met, and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity i syphilis tp reagent for lot 28077be01 was identified.

Event Description

The customer observed a false nonreactive alinity i syphilis tp result for a 61 year old male patient that was questioned by the physician.The following data was provided: (b)(6) 2022, sid (b)(6), initial result = 0.86 s/co, repeat = 0.99 s/co (nonreactive), autobio platform = positive, tppa = positive.Additional laboratory data was provided: hbsag = 0.00 iu/ml , anti-hbs = 0.33 miu/ml, hbeag = 0.40 s/co, anti-hbe = 1.90 s/co, anti-hbc = 3.2 6s/co, anti-hcv = 0.07s/co.The patient is an hiv/aids patient.No impact to patient management was reported.

• 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: 13595123
• MDR Text Key: 289604042
• Report Number: 3002809144-2022-00065
• 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
• Report Date: 04/03/2022

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: 04/07/2022
• Device Catalogue Number: 07P60-74
• Device Lot Number: 28077BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 04/03/2022
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI22189.; ALNTY I PROCESSING MODU, 03R65-01, AI22189.
• Patient Age: 61 YR
• Patient Sex: Male