MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT

Model Number N/A

Device Problems False Negative Result (1225); False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2020

Event Type  malfunction  

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 07p60-22 that has a similar product distributed in the us, list number 07p60-21.

Event Description

The customer reported a false non-reactive alinity i (b)(6) tp result on a patient.The following data was provided: on (b)(6) 2020 sid (b)(6) = initial 0.18 s/co (non-reactive) / repeat 1.30, 1.29 s/co (reactive).The customer retested the patient sample on an architect analyzer and generated results of 1.31, 1.32,1.26 s/co (reactive).There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for an initial false non-reactive result for one sample tested with the alinity i syphilis tp assay 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 inhouse testing of retained kits with the complaint lot number.No customer returns were available.The trending review determined no trends related to the complaint for the product.The device history record review did not identify any non-conformances or deviations with the reagent lot and complaint issue.The inhouse testing determined that the sensitivity performance is not negatively impacted.The labelling review concluded that the issue was adequately addressed.Based on the investigation it is determined that there is no systemic issue and no product deficiency identified with the alinity i syphilis tp reagent lot 07418be00.Section d11: concomitant medical products and therapy dates - updated list number from 03r65-0 to 03r65-01 section h6: event problem and evaluation codes - changed from device code of 1227 to device code of 1225.

• Brand Name: ALINITY I SYPHILIS TP REAGENT KIT
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10211253
• MDR Text Key: 230614568
• Report Number: 3002809144-2020-00538
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• 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: 07/22/2020

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: 07/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 07P60-22
• Device Lot Number: 07418BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE,; ALINITY I PROCESSING MODULE,; LIST 03R65-0, SERIAL (B)(6); LIST 03R65-01, SERIAL (B)(6)