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

Model Number PA0792

Device Problem Off-Label Use (1494)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907)

Event Date 02/19/2018

Event Type  Injury  

Event Description

On 2/19/2018, a call was received from the university of penn director of occupational medicine dr.(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 headached 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.

Manufacturer Narrative

This report is being submitted retrospectively per fda request.Patient code: 2688 in 2018 and has since been updated per fda.Method code: 3323 in 2018 and since has been updated to 4111 per fda.

• Brand Name: C4D (SP91)
• Type of Device: RABBIT MONOCLONAL PRIMARY ANTIBODY
• Manufacturer (Section D): CELL MARQUE CORPORATION; 6600 sierra college blvd.; rocklin CA 95677
• Manufacturer (Section G): CELL MARQUE CORPORATION; 6600 sierra college blvd; rocklin CA 95677
• Manufacturer Contact: frieda casey ; 6600 sietta college blvd; rocklin, CA 95677 ; 9167468977
• MDR Report Key: 7975541
• MDR Text Key: 315848074
• Report Number: 1649339-2018-00001
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: PA0792
• Device Catalogue Number: PS0792
• Device Lot Number: 52743
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male