MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD CD81 APC-H7 (JS-81) ASR

Model Number	656154
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during use they were losing apc channel resolution with a bd cd81 apc-h7 (js-81) asr.The following information was provided by the initial reporter: the customer found tandem dye degradation after using a period before expiry date.
Event or Problem Description
It was reported that during use they were losing apc channel resolution with a bd cd81 apc-h7 (js-81) asr.The following information was provided by the initial reporter: the customer found tandem dye degradation after using a period before expiry date.
Additional Manufacturer Narrative
H.6.Investigation: ¿ manufacturing defect trend: from 07/20/2020 back to 06/20/2019, no qn was generated in sap for the following materials: 656154 and 91-0885.¿ complaint trend: aside for this pir#1644280, there is no other pir complaint reported for catalog# 656154 from date 01jul2020 back to 01jul2019.¿ batch history record review: reviewed production batch records for material 656154-9060975 and the in-process material 91-0885-9022655.Batch record review of 656154-9060975 showed that the product complies with all the qc released criteria.Batch record review of 91-0885-9022655 showed that product passed all the qc specifications as designed.¿ result of retain sample testing: retain sample of 91-0885-9022655 sample was used to stain with normal peripheral blood.The reagent cocktail also contain cd45 fitc and cd3 pe to aid in the gating of the blood cell populations.Staining result showed that the following populations: lymphocytes, monocytes and eosinophils were positive for cd81 apch7.Neutrophils showed as a negative population.The product functioned as intended.¿ result of returned sample evaluation: a task was created 1660982, to request for a dot plot sample from the customer.Three attempts to contact the customer by the customer complaint specialist.As of this writing, july 20, no response from the customer was received.As per communication with customer complaint specialist, the reagent was used after the assigned expiration date.¿ investigation result / analysis: retain sample of 91-0885-9022655 sample was used to stain with normal peripheral blood.The reagent cocktail also contain cd45 fitc and cd3 pe to aid in the gating of the blood cell populations.Staining result showed that the following populations: lymphocytes, monocytes and eosinophils were positive for cd81 apch7.Neutrophils showed as a negative population.The product functioned as intended.¿ risk analysis: reviewed risk analysis document: sap#100311ra rev06, entitled antibody and antibody conjugates asr-ruo document hazard(s) identified? yes hazard #: 3.Functional 3.1.3 functional hazard cause: product degradation before assigned expiration date.Harmful effects: aberrant result probability: 2 severity: 3 risk index: 6 initial risk evaluation: unacceptable risk control: real time stability study implementation verification: qs stability study efmc-15-37p efmc-16-39p clinical trial accuracy study protocol (cas-efmacc4 mitigation(s) sufficient: yes ¿ attached pics/docs from investigation: pir# 164480 cd81 apch7 attachment.¿ root cause: no root cause identified.Product functioned as intended.¿ investigation conclusion the complaint is unconfirmed as a manufacturing defect.The product functioned as intended.

• Brand Name: BD CD81 APC-H7 (JS-81) ASR
• Common Device Name: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10271029
• Report Number: 2916837-2020-00058
• Device Sequence Number: 3458308
• Product Code: MVU
• UDI-Device Identifier: 00382906561541
• UDI-Public: 00382906561541
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2020
• Device Model Number: 656154
• Device Catalogue Number: 656154
• Device Lot Number: 9060975
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other