MAUDE Adverse Event Report: GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY; HIV-1/HIV-2/HCV/HBV DEVICE

Catalog Number	731774
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, grifols customer, grifols customer (b)(6) (pakistan) reported one sample that was nonreactive with ultrio elite (ue) and serology (assays unknown) but was reactive for hbv in "roche 6800".Fresh frozen plasma from the same donation was retested in ue (nonreactive) and roche (reactive).The customer requested an explanation for the discordant results.Due to the reactive result from the roche, the donation was not used.No sample remains for investigation.A previous events search for hbv sensitivity issues across all ue master lots was performed and no trends were identified that indicated a loss of sensitivity in any ue reagent master lot.A risk assessment was performed.The severity of a blood screening false negative result is critical, as use of an infected donation can cause multiple infections.The probability of a false negative result is remote based on the previous events search.False negative results do occur but are rare.Following iso 14971, grifols risk assessment is based on severity of a harm or impact to human health and the probability of occurrence of harm or impact to human health.Based on the severity rating of 'critical' and probability rating of 'remote', the overall risk posed by a false negative ultrio elite result is determined to be acceptable.No impact to product was identified.Ue master lots are not released to the customer without passing release criteria.A previous events search in the grifols complaint system indicates that the assay is working as designed.The impact to the customer was questioning the disagreement between the ultrio elite and roche assays.An investigation is ongoing for the discordant hbv result pending receipt of basic information requested including results reports, assay names used, reagent master lot used, and sample handling information has been requested.Grifols also requested the customer testing protocol as it is suspected the customer was performing an evaluation of the ue assay and the roche assay rather than normal donor screening.Ue master lots are released to the customer after they pass the release criteria.A previous events search in the grifols complaint system indicates that the assay is working as designed.Follow-up information for this report will be provided when available.
Event or Problem Description
On 15feb2024, grifols customer, grifols customer armed forces institute of transfusion (pakistan) reported one sample that was nonreactive with ultrio elite (ue) and serology (assays unknown) but was reactive for hbv in "roche 6800".Fresh frozen plasma from the same donation was retested in ue (nonreactive) and roche (reactive).The customer requested an explanation for the discordant results.Due to the reactive result from the roche, the donation was not used.No sample remains for investigation.A previous events search for hbv sensitivity issues across all ue master lots was performed and no trends were identified that indicated a loss of sensitivity in any ue reagent master lot.A risk assessment was performed.The severity of a blood screening false negative result is critical, as use of an infected donation can cause multiple infections.The probability of a false negative result is remote based on the previous events search.False negative results do occur but are rare.Following iso 14971, grifols risk assessment is based on severity of a harm or impact to human health and the probability of occurrence of harm or impact to human health.Based on the severity rating of 'critical' and probability rating of 'remote', the overall risk posed by a false negative ultrio elite result is determined to be acceptable.No impact to product was identified.Ue master lots are not released to the customer without passing release criteria.A previous events search in the grifols complaint system indicates that the assay is working as designed.The impact to the customer was questioning the disagreement between the ultrio elite and roche assays.An investigation is ongoing for the discordant hbv result pending receipt of basic information requested including results reports, assay names used, reagent master lot used, and sample handling information has been requested.Grifols also requested the customer testing protocol as it is suspected the customer was performing an evaluation of the ue assay and the roche assay rather than normal donor screening.Ue master lots are released to the customer after they pass the release criteria.A previous events search in the grifols complaint system indicates that the assay is working as designed.Follow-up information for this report will be provided when available.23may2024: follow-up information: no additional information was provided.The root cause of the disagreement between ue and roche/ serology is likely low titer hbv, but this could not be confirmed due to lack of sample for investigation.Intermittent reactive results are expected in low titer samples (at or below the 95% lod of the ue assays).Based on the previous events search and qc release data processes in place, the ultrio elite assay is working as designed no further information is expected, this is the final report.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Common Device Name: HIV-1/HIV-2/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: jin shi ; 10808 willow court; san diego, CA 92127 ; 8582020806
• MDR Report Key: 18909141
• Report Number: 2032600-2024-00002
• Device Sequence Number: 6971742
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: BL125652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 731774
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown