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

Model Number	7K77-25
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11700441
• Report Number: 3005094123-2021-00070
• Device Sequence Number: 3998107
• Product Code: JLS
• UDI-Device Identifier: 00380740014919
• UDI-Public: 00380740014919
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 07/12/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/25/2021; 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD, 01L86-01, I1SR02332; ARC I1000SR MOD, 01L86-01, I1SR02332; ARC I1000SR MOD, 01L86-01, I1SR02332; ARC PROGEST CTL, 07K77-10, UNKNOWN