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

Catalog Number 731770

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, customer (b)(6), (italy) reported non-reactive result on ultrio elite screening assays and intermittent reactivity upon retests.Sample collected on (b)(6) 2023 from (b)(6) (test tube code (b)(6)).Reported as collection of autologous stem cells from hiv positive patient; patient under therapy.On (b)(6) 2023, sample tested on panther 10443 (lot ultrio elite 706348 expiring 9/15/24) edta plasma processed sample.Negative result (s/co 0.06, rlu 6855).On (b)(6) 2023, sample tested on panther 10422 (lot ultrio elite 706348 expiring 9/15/24) sample processed serum.Negative result (s/co 0.05, rlu 5612).On (b)(6) 2023, sample tested on panther 10421 (lot ultrio elite 706348 expiring 9/15/24) sample processed serum.Positive result (s/co 8.54 , rlu 855246).Date unkown, the repeat values for the hiv ag/ab profile are as follows: 979 s/co, 986 s/co, 990 s/co, serology results are from instrument architect (abbott) (qualitative test).The sample is likely a low titer hiv sample due to the retroviral treatment, which is known to give intermittent reactive results.No injury, death or medical intervention was reported for this incident because the transfusion was autologous and the donor was known for being hiv positive.Follow-up information for this report will be provided when available.

Event Description

On 19jul2023, customer (b)(4) (italy) reported non-reactive result on ultrio elite screening assays and intermittent reactivity upon retests.Sample collected on (b)(6) 2023 from reggio emilia (test tube code 1023080102).Reported as collection of autologous stem cells from hiv positive patient; patient under therapy.On (b)(6) 2023, sample tested on panther 10443 (lot ultrio elite 706348 expiring 9/15/24) edta plasma processed sample; negative result (s/co 0.06, rlu 6855).On (b)(6) 2023, sample tested on panther 10422 (lot ultrio elite 706348 expiring 9/15/24) sample processed serum; negative result (s/co 0.05, rlu 5612).On (b)(6) 2023, sample tested on panther 10421 (lot ultrio elite 706348 expiring 9/15/24).Sample processed serum.Positive result (s/co 8.54 , rlu 855246).Date unknown, the repeat values for the hiv ag/ab profile are as follows: 979 s/co; 986 s/co; 990 s/co.Serology results are from instrument architect (abbott) (qualitative test) the sample is likely a low titer hiv sample due to the retroviral treatment, which is known to give intermittent reactive results.No injury, death or medical intervention was reported for this incident because the transfusion was autologous and the donor was known for being hiv positive.Follow-up information for this report will be provided when available.Follow-up information: remaining sample volume was returned to grifols san diego for quantification.Two serum vials with remaining volume were received 08282023 and tested in the aptima hiv-1 quant assay on 08292023.The vials were previously used for the serology testing and two of the three ultrio elite results.The aptima hiv quant assay is not validated for monitoring titer in hiv-1 patients undergoing antiretroviral therapy in serum specimens.Since no plasma was available for return, the serum samples were tested.Testing details: 29aug2023 : serum sample vial 1.Aptima quant hiv-1.Result: <30 c/ml detected ltr (hiv-1 rna is detected but at a level below the lloq).29aug2023 : serum sample vial 2 aptima quant hiv-1 result: hiv-1 rna not detected.The limit of detection (lod) for the aptima hiv-1 quant dx assay in plasma is 12 copies/ml.The lower limit of quantitation (lloq) for the aptima hiv-1 quant dx assay in plasma is 15 copies/ml.This performance was established with the hiv-1 who international standard (10/152) in hiv-1 negative plasma.These results are for investigational purposes only and are consistent with low titer hiv-1.The root cause of the nonreactive ultrio elite results was confirmed to be low titer hiv-1, which is expected in patients under hiv anti-retroviral treatment for hiv-1.Intermittent reactive results are expected in low titer samples.Review of the qc release data and a previous events search indicate the ultrio elite assay is working as designed.No further information is expected, this is the final report.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Type of Device: 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: 17567444
• MDR Text Key: 321406616
• Report Number: 2032600-2023-00010
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007665
• UDI-Public: 00859882007665
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 731770
• Device Lot Number: 706348
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other