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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.All available patient information has been included.No additional patient details are available.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 (b)(6) tp result when compared to other methods on a (b)(6) year-old female patient who previously tested positive.The results provided were: sid (b)(6) generated an initial result of 0.92 s/co (nonreactive), repeated 1.04 s/co (reactive) (the cutoff is <1.00 s/co = nonreactive); the specimen generated tppa positive results.Historical results were provided: (b)(6) 2020 (b)(6) results = 1.08 / 1.18 s/co (reactive), rpr was negative, and tppa was positive.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation 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.Return testing was not completed as returns were not available.Review of tracking and trending reports did not identify any related trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the lot and the complaint issue.A review of the product labeling concluded that the issue is adequately addressed.A retained reagent kit of the complaint lot was tested in a specificity setup.All specifications were met, and no false reactive results were obtained, indicating that the specificity performance is acceptable.Based on the investigation, no systemic issue or deficiency with the alinity i syphilis tp reagent lot(s) 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
• MDR Report Key: 10808370
• MDR Text Key: 241306302
• Report Number: 3002809144-2020-01097
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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 Catalogue Number: 07P60-77
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/05/2021
• 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: 36 YR