MAUDE Adverse Event Report: SEBIA CAPI 3 IMMUNOTYPING; IMMUNOGLOBULINS BY CAPILLARY ELECTROPHORESIS

Model Number	2600
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
18 august 2021: the customer observed that one kit of the capi 3 immunotyping antisera cartridge out of the 50 kits received, lot 11021/01, presented with discordant results.Visual inspection identified that two of the antisera anti-iga and anti-igm were reversed in the positions within the sealed cartridge.No discrepant patient laboratory reports were released.There were no reports of impact to patient management.
Additional Manufacturer Narrative
19 august 2021: the customer contacted sebia inc., (us subsidiary of sebia), technical support team in regards to an inversion of two antisera in a single capi 3 immunotyping cartridge.No patient results were impacted.All other products received by the customer were in compliance.Sebia inc.,(us importer) inspected all capi 3 immunotyping stock and all products were complaint.Product alert letters were sent to all customers globally that received capi 3 immunotyping kits of lot 11021/01.The letter instructed customers to visually inspect kits, review quality control if product was placed into use for conformance.A total of (b)(4) kits were shipped to us customers of (b)(4) kits sebia manufactured.The customers were requested to complete a bounce back notification on the number of kits inspected and identify kit(s) that were no-compliant.The issue was limited to one kit.The error was traced to human error in packaging and corrective measures have been implemented with an additional control step at the manufacturing site.

• Brand Name: CAPI 3 IMMUNOTYPING
• Common Device Name: IMMUNOGLOBULINS BY CAPILLARY ELECTROPHORESIS
• Manufacturer (Section D): SEBIA; 27 street; parc tech leonard de vinci; evry, lisses france 91008 ; FR 91008
• MDR Report Key: 12482986
• Report Number: 8023024-2021-00001
• Device Sequence Number: 13684000
• Product Code: CFF
• UDI-Device Identifier: 03607360026007
• UDI-Public: 03607360026007
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 01/31/2023
• Device Model Number: 2600
• Device Catalogue Number: 2600
• Device Lot Number: 1102101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other