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

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.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 false reactive alinity i (b)(6) assay results for one blood donor.The customer provided: donor sample initial = 11.49 s/co, repeat 11.65 s/co, 11.77 s/co (ref range: < 0.10 s/co = nonreactive; equal to or > 1.00 s/co reactive).The sample was tested with an immunoblot and an alternative chemiluminescence test and was stated to be nonreactive with both.There was no impact to patient management reported.

Manufacturer Narrative

After further evaluation, the initial emdr was created and submitted in error.Suspect medical device 07p60-22 architect syphilis tp is not a screening assay in the united states and therefore not reportable.No impact to patient management was reported.Based upon this review, this complaint is no longer a reportable event and no further follow up will be provided.

• 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: 10263434
• MDR Text Key: 230623377
• Report Number: 3002809144-2020-00630
• 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: 09/04/2020

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: 11/11/2020
• Device Model Number: N/A
• Device Catalogue Number: 07P60-22
• Device Lot Number: 11054BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE; ALINITY I PROCESSING MODULE; LN 03R65-01, SN (B)(6); LN 03R65-01, SN (B)(6)