MAUDE Adverse Event Report: BIOCARE MEDICAL CD30 (KI-1)

Model Number N/A

Device Problem False Negative Result (1225)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Notes regarding above "unknown" responses: patient information: unknown.Biocare medical reached out to the (b)(4) distributor on 03/17/2020,03/21/2020, 04/01/2020, 04/17/2020, and 04/22/2020.The distributor provided very limited data to allow successful evaluation.In addition, on 04/26/2020, distributor indicated the pathologist and hospital would like to drop the case.Hence no additional technical and regulatory details could be obtained.Adverse event or product problem: due to limited information, biocare medical cannot provide date of adverse event, relevant tests/laboratory date, and patient's preexisting medical conditions for reporting.Suspect products: mr.(b)(6) only provided product name and catalog number; however lot number was not provided to biocare medical.Therefore, this information is unknown.Biocare medical reached out to the (b)(4) distributor on 03/17/2020,03/21/2020, 04/01/2020, 04/17/2020, and 04/22/2020.The distributor provided very limited data to allow successful evaluation.In addition, on 04/26/2020, distributor indicated the pathologist and hospital would like to drop the case.Hence no additional technical and regulatory details could be obtained.Not applicable.Suspect medical device: lot number and expiration date are unknown to date due to limited information from mr.(b)(6).Device manufacturers only: biocare medical did not initiate a remedial action due to limited information provided by mr (b)(6).In addition, biocare medical did not receive additional complaints related to adverse event from its customers who also purchased this antibody.As part of due diligence, biocare medical also performed technical review of the original design testing and product surveillance data.Upon review, with almost twelve years of historic data, biocare medical feels confident in this product and see no justification for withdrawal from the market.

Event Description

An (b)(4) distributor informed biocare medical at a tradeshow (uscap) on (b)(6) 2020 that biocare medical's cd30 (ki-1) antibody's sensitivity is weak and yielded false-negative staining.According to the distributor this resulted in delayed diagnosis and a patient's death.

• Brand Name: CD30 (KI-1)
• Type of Device: CD30 (KI-1)
• Manufacturer (Section D): BIOCARE MEDICAL; 60 berry drive; pacheco, ca
• Manufacturer (Section G): BIOCARE MEDICAL; 60 berry drive; pacheco, ca
• Manufacturer Contact: johanna saito ; 60 berry drive; pacheco, ca ; 6038093
• MDR Report Key: 10246458
• MDR Text Key: 197991346
• Report Number: 3004140393-2020-00001
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM346
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death