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 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier : case #1 ( 55-year-old male) / case #2 (40-year old male) ( 2 separate patients).This report is being filed on an international product, list number 07p60-77 that has a similar product distributed in the us, list number 07p60-21 / 31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false nonreactive alinity i syphilis tp result for 2 patient cases compared to other methods.The following data was provided (reference range is < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): case#1 (in-patient: 55-year-old male diagnosed with colon polyps).Alinity i syphilis result: 0.52 s/co (nonreactive).Fuji manual tppa test result: positive.Johnson &johnson platform: 4.09 s/co (positive).Case #2 (out-patient: 40-year-old male diagnosed with infertility).Alinity i syphilis result: 0.84 s/co (nonreactive).Fuji manual tppa test result: positive.Johnson & johnson platform: 1.92 s/co (positive).The customer also used an industrial scientific colloidal gold strip which showed a negative result for both patient samples.The first patient sample (case #1) was tested 2 days later with trust and obtained a negative result.The customer believed both alinity i syphilis results were false negative for both patient cases.The customer reported out the positive result to the clinical physician who had no questions about the result at the time.No confirmatory testing on the sample has been provided by the customer.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i syphilis tp results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of tracking and trending did not identify any related trends.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met, and no false non-reactive results were obtained, showing that the lot generates the expected results.The device history records were reviewed and did not identify any non-conformances or deviations associated with the lot number 35058be01 and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity i syphilis tp reagent lot 35058be01 was identified.

• 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: 15100251
• MDR Text Key: 304811341
• Report Number: 3002809144-2022-00263
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Catalogue Number: 07P60-77
• Device Lot Number: 35058BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).