MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC. PD-L1 IHC 22C3 PHARMDX; IMMUNOHISTOCHEMISTRY

Catalog Number SK006

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/06/2016

Event Type  malfunction  

Event Description

Due to a malfunction in agilent's order management system/service affecting order entry and shipment, there was a delay in delivering pd-l1 ihc 22c3 pharmdx kits to the customer.It was reported to dako that the testing of the patient biopsy was delayed for several weeks, the consequence of which is a possible critically clinical delay in diagnosis of a patient that could lead to delay in treatment.

Manufacturer Narrative

Follow-up information: (b)(6) 2017: patient incident.Dako received information that the patient passed away.Date of death was not provided for which reason date of incident is not stated.Moreover, information was not provided as to whether the patient received any treatment.Due to product delivery delay of more than two weeks, the test result of pd-l1 could not be provided, hence the treatment of a male patient could have been delayed.Further information has been provided that the patient died the day after the test result could have been delivered to the oncologist.Investigation actions and timelines · nov 7, 2016: (b)(6) (customer) submitted purchase order for 3 pd-l1 ihc kits.Backorder due to integration issue of new order entry system rolled out nov 1, 2016.· nov 26.2016: entry reestablished, and shipping date was dec 7, 2016.Fed ex confirmed delivery to customer on dec 8, 2016.· nov 22, 2016: dako country manager for ca, contacted customer on delayed delivery.· dec 6, 2016: oncologist is in contact with customer to elaborate on delay of diagnose and patient situation.Customer forward communication to dako on dec 7, 2016.· dec 13, 2016 through jan 4, 2017: investigation and request to oncology for more medical important information.· jan 9, 2017: the dako management team decides that a delay in delivery exceeding 4 weeks can lead to serious injury.· jan 25, 2017: dako has requested additional patient information from the oncologist.Information is awaited.

Manufacturer Narrative

Final follow-up information: patient incident: dynacare did not have the pd-l1 ihc 22c3 pharmdx kit and there was a delivery delay determined to be 4 weeks and 4 days from agilent; this delay of delivery was confirmed by the oncologist.During the delay, the oncologist attempted both to send the specimen to other local labs for testing, and also sent the patient to an academic institution to receive immunotherapy care under a compassionate use protocol.The attempt to get testing done at alternative labs was unsuccessful as none of the other local labs contacted had the pd-l1 ihc 22c3 pharmdx kit.The attempt to treat the patient under a compassionate use protocol was not approved by canada's nationalized health care system and the patient could not afford the treatment personally.According to the oncologist, it was not possible to provisionally treat the patient with keytruda¿ without pd-l1 results due to regulations surrounding canada's nationalized health care policies.The patient continued to deteriorate during the 4 weeks and passed away before the test was performed.It is unknown if the treatment would have improved the quality of life or prolonged the life of the patient.Additionally, the pd-l1 ihc 22c3 pharmdx kit is new to the market and this is the only approved diagnostic for keytruda¿.System incident: corrective actions taken as a result of the investigation.· go-live for our new erp / crm (moving from oracle and sales force to sap) on november 1, 2016.· go-live on november 1 was prepared by a cross-functional team for over 1 year.· in scope for the new erp / crm was the entire quote to invoice process, including every step from customer order entry to shipment of product and invoicing.· a dedicated task force was in place before/after go-live to address issues with this significant system change, including a daily senior management report-out / review.· operational teams in order management and logistics operated with incremental resources and up to 3 shifts, and week-ends for 2 months after go-live to mitigate any slow-down in efficiency due to these system changes (and adaption of the new system) · we experienced a slower-than-normal turnaround time (order to shipment) in the first weeks after go-live.With a concerted effort as outlined above we have been able to resume normal operation in december.

• Brand Name: PD-L1 IHC 22C3 PHARMDX
• Type of Device: IMMUNOHISTOCHEMISTRY
• Manufacturer (Section D): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria 93013
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 1170 mark ave; carpinteria CA 93013
• Manufacturer Contact: joel weisenberger ; 6392 via real; carpinteria,, CA 93013 ; 8055665432
• MDR Report Key: 6244459
• MDR Text Key: 65060716
• Report Number: 2022180-2017-00001
• Device Sequence Number: 1
• Product Code: PLS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2017

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
• Device Operator: Other
• Device Catalogue Number: SK006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 03/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other