MAUDE Adverse Event Report: CELL MARQUE CORPORATION C4D (SP91); RABBIT MONOCLONAL PRIMARY ANTIBODY

Model Number PA0792

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Headache (1880); Pain (1994); Rash (2033); Reaction (2414)

Event Date 02/19/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a call was received from (b)(6).She called to report that seven patients (6 females and 1 male) and employees of the hospital, came in to have an annual tb screening.All seven patients were injected with c4d (sp91) rabbit polyclonal antibody, predilute in a leica bond dispenser.The nurse practitioner assumed she was injecting tuberculin purified protein derivative also know as tubersol used in the testing for tb.Post injection six of the patients experienced the following physiological symptoms: - five of the seven patients experience headaches.- two patients had an allergic reaction.- one of the two patients experienced a delayed headache and developed a rash.The person with the delayed reaction had a severe headache with joint pain at the injection site.The patient was given a steroid and a antihistamine as well as a ct scan.The error was discovered within 2 hours of injection.At the treating physician's request and advice of the eh&s officer, the safety data sheet (sds) documents for the antibody, sodium azide and bovine serum were provided.Relevant.

Manufacturer Narrative

This is a final report that no additional information or medical issues have been reported to cell marque corporation for this adverse event.

• Brand Name: C4D (SP91)
• Type of Device: RABBIT MONOCLONAL PRIMARY ANTIBODY
• Manufacturer (Section D): CELL MARQUE CORPORATION; 6600 sierra college blvd.; rocklin CA 95677
• MDR Report Key: 7974874
• MDR Text Key: 124083123
• Report Number: 1649339-2018-00006
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/14/2020
• Device Model Number: PA0792
• Device Catalogue Number: PA0792
• Device Lot Number: 52743
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention