MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT PROGESTERONE REAGENT KIT; RADIOIMMUNOASSAY, PROGESTERONE

Model Number 7K77-25

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

Was this device service by a third party? no.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The male user of the architect i1000sr reported a splash to the eye with the architect progesterone control.His eyes were flushed with water and saline.The user was wearing a lab coat and gloves, but not eye goggles.No impact to patient management was reported.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

Manufacturer Narrative

Use error may have contributed to the complaint issue regarding the use of personal protective equipment (ppe) while using the product.No protective eyewear as per product labeling was in use at the time of the incident.No trends or similar issues for splashing/exposure as described in this ticket were identified.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the biological and chemical safety hazards that may exist including the wearing of personal protective equipment (ppe).Based on the investigation no systemic issue or product deficiency was identified.

• Brand Name: ARCHITECT PROGESTERONE REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11700441
• MDR Text Key: 251205751
• Report Number: 3005094123-2021-00070
• Device Sequence Number: 1
• Product Code: JLS
• UDI-Device Identifier: 00380740014919
• UDI-Public: 00380740014919
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2021
• Device Model Number: 7K77-25
• Device Catalogue Number: 07K77-25
• Device Lot Number: 22526UI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR02332; ARC I1000SR MOD, 01L86-01, I1SR02332; ARC I1000SR MOD, 01L86-01, I1SR02332; ARC PROGEST CTL, 07K77-10, UNKNOWN