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

Catalog Number 07P60-74

Device Problem False Negative Result (1225)

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

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) alinity (b)(6) results on one patient.The results were provided: on (b)(6) 2020 sid (b)(6) initial (b)(6) result(b)(6)/ repeated on colloidal gold method result=(b)(6)/repeated on other i2sr analyzer (b)(6) result=(b)(6)/ inco"s new colloidal gold result=(b)(6) /rpr result=(b)(6), tppa result=(b)(6).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets was performed for alinity i syphilis tp reagent lot number 10030be01.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A retained reagent kit of lot number 10030be01 was tested in a sensitivity setup, including additional replicates of a sensitivity panel.Results of this setup did not implicate that the performance of the lot was negatively impacted.No false non-reactive results were obtained.Manufacturing documentation for the reagent lot was reviewed and did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the alinity i syphilis tp assay lot number 10030be01 assay was identified.

Manufacturer Narrative

Corrected common device product code: updated product code: to lip from mtn.

• Brand Name: ALINITY I SYPHILIS TP REAGENT KIT
• Type of Device: ALINITY I SYPHILIS TP
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9985817
• MDR Text Key: 188735249
• Report Number: 3002809144-2020-00338
• 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,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Catalogue Number: 07P60-74
• Device Lot Number: 10030BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE.; ALINITY I PROCESSING MODULE.; ALINITY I PROCESSING MODULE.; LN 03R65-01, SERIAL (B)(4). ; LN 03R65-01, SERIAL (B)(4).; LN 03R65-01, SERIAL # (B)(4).