NIVOLUMAB, 240 MG PD-I1 IHC NIVOLUMAB PHARMDX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-29 for NIVOLUMAB, 240 MG PD-I1 IHC NIVOLUMAB PHARMDX manufactured by Dako North America.

Event Text Entries

[98676421] On (b)(6) 2018 patient presented for his first lutathera infusion, and second nivolumab infusion. Towards the end of the lutathera infusion, patient developed hypoxia, oxygen saturation dropped to 85 percent to 86 percent, and he began receiving 2l on nc, which eventually had to be increased to 4l due to little improvement, even at rest. He also developed a dry, non-productive cough towards the end of the lutathera infusion but the cough improved after using 2 puffs of his albuterol inhaler that he brought from home, and receiving cough syrup. At around 4pm, dr. (b)(6) came to see the patient again, and noted inspiratory and expiratory wheezing and decided to extend his hospitalization for further work-up. As of (b)(6) 2018 patient is still under observation. Event unlikely related to clinical trial drugs as per oncologist. Dose or amount: 240 mg, frequency: every 2 weeks, route: intravenous (not otherwise specified). Dates of use: (b)(6) 2018. Diagnosis or reason for use: small cell lung cancer. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074945
• MDR Report Key: 7227790
• Date Received: 2018-01-29
• Date of Report: 2018-01-26
• Date of Event: 2018-01-25
• Date Added to Maude: 2018-01-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: NIVOLUMAB, 240 MG PD-I1 IHC NIVOLUMAB PHARMDX
• Generic Name: IMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY
• Product Code: NQF
• Date Received: 2018-01-29
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DAKO NORTH AMERICA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2018-01-29