MAUDE Adverse Event Report: CELL MARQUE CORPORATION KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY

Model Number 274R

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

Cell marque purchased the correct material, kappa (ep171) however, the vendor shipped lambda (ep172).Review of purchase order showed the correct was ordered, kappa (ep171) from the supplier but the incorrect product was sent instead lambda (ep172).Review of customer complaints, 2 out of 3, were reporting and indicating that they were observing the same positive staining on the kappa as the lambda antibody.The customers questioned as to whether the material in the vials were accurate.Five finished product lots of kappa (ep171) rabbit monoclonal antibody were filled with lambda (ep172) rabbit monoclonal antibody.The lots affected were: 0000057589,0000057588,0000057618, 0000057617, 0000064775.Relevan part #s: 274r-14 - ruo, 274r-14, 274r-17, 274r-18 the product is therefore misbranded and the labeling does not represent the content.

• Brand Name: KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY
• Type of Device: KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY
• Manufacturer (Section D): CELL MARQUE CORPORATION; 6600 sierra college boulevard; rocklin CA 95677
• MDR Report Key: 8848973
• MDR Text Key: 217435977
• Report Number: 1649339-2019-00001
• 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
• Type of Report: Initial
• Report Date: 07/30/2019

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 274R
• Device Catalogue Number: 274R
• Device Lot Number: 57588, 64775, 57617, 57618
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1