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 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive alinity i syphilis tp results for a 39-year-old pregnant female patient who was recently positive.The alinity i syphilis tp result on (b)(6) 2022 was 0.75 s/co (nonreactive), and the trust was negative; the baby was born (b)(6) 2022, on (b)(6) 2022 the alinity i syphilis tp result 0.58 s/co (nonreactive).The baby girl was collected on (b)(6) 2022 and the alinity i syphilis tp result was 1.26 s/co, trust was negative.The patient¿s historical results: (b)(6) 2022 alinity i syphilis tp 1.26 s/co, (b)(6) 2022 tppa+, (b)(6) 2022 trust, (b)(6) 2022 tppa+1:80, (b)(6) 2022 trust, (b)(6) 2022 trust, (b)(6) 2022 trust, (b)(6) 2022 trust, (b)(6) 2022 alinity i syphilis tp 0.75 s/co, (b)(6) 2022 trust, (b)(6) 2022 alinity i syphilis tp 0.58 s/co.The results of the baby girl born to the pregnant woman are as follows: (b)(6) 2022 alinity i syphilis tp 1.26 s/co, (b)(6) 2022 trust.Because the patient was previously positive for syphilis, the syphilis unreactive 0.75 s/co was detected before delivery on july 20.Through further verification of patient information, her husband was also infected with syphilis.No impact to patient management was reported.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed on lot 35058be01, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue of falsely reactive results.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.Based on all reviewed data, we conclude that there is no product deficiency with the alinity i syphilis tp reagent identified in this complaint.

• 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: 15193395
• MDR Text Key: 305244439
• Report Number: 3002809144-2022-00274
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• 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: 08/22/2022
• 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)
• Patient Age: 39 YR
• Patient Sex: Female