MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HBCORE ASSAY KIT; HEPATITIS B VIRUS CORE ANTIGEN (E. COLI, RECOMBINANT)

Catalog Number	06E66-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer stated that a false reactive prism hbcore result was generated.The following data was provided.(b)(6) 2022.Sample id (b)(6).Hbcore results: repeat reactive 0.89, 0.93, and 0.94 s/co.The sample tested nonreactive on the alinity s processing module which is believed to be correct.Supplemental testing was nonreactive/negative for hbsag and hbv pcr.No impact to donor or patient management was reported.
Additional Manufacturer Narrative
Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.To evaluate clinical specificity of prism hbcore reagent lot 35001m700, the lot and a reference lot (39006m700) were tested in a specificity setup inclusive of replicates of the negative control and a negative human population panel.The testing passed all validity and acceptance criteria.All generated data demonstrates that the prism hbcore reagent lot 35001m700 is performing as expected.No deficiency was identified.

• Brand Name: ABBOTT PRISM HBCORE ASSAY KIT
• Common Device Name: HEPATITIS B VIRUS CORE ANTIGEN (E. COLI, RECOMBINANT)
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14936088
• Report Number: 1415939-2022-00050
• Device Sequence Number: 5035570
• Product Code: QHM
• UDI-Device Identifier: 00380740062965
• UDI-Public: 00380740062965
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: Health Professional
• Device Expiration Date: 08/13/2022
• Device Catalogue Number: 06E66-68
• Device Lot Number: 35001M700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRSM NEXT RFRB IN, 06A36-11, 01175-96.; PRSM NEXT RFRB IN, 06A36-11, 01175-96.
• Patient Sex: Unknown