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.
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