MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HTLV-I/HTLV-II ASSAY KIT; HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II

Catalog Number	06E50-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported (b)(6) prism htlv-i/htlv-ii results on multiple patients when performing a validation study on the alinity s analyzer.All of the (b)(6) prism samples tested negative on the alinity s.Western blot (wb) testing was (b)(6) for all but one sample, which was indeterminate (ind).Results provided: (b)(6) results (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Patient identifier sids: (b)(6).
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause abbott prism htlv-i/htlv-ii identified normal complaint activity.As the lot numbers are unknown, the performance of the likely cause list number (6e50-68) was investigated by completing a review for non-conformances, potential non-conformances and deviations.This review did not identify any non-conformances, potential non-conformances or deviations for the list number.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.A review of overall customer field data was performed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for list number 6e50-68.The irr, the rrr and the specificity of the list number is within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.No systemic issue or product deficiency was identified.

• Brand Name: ABBOTT PRISM HTLV-I/HTLV-II ASSAY KIT
• Common Device Name: HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II
• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13177770
• Report Number: 1415939-2022-00002
• Device Sequence Number: 17272631
• Product Code: QHM
• UDI-Device Identifier: 00380740063016
• UDI-Public: 00380740063016
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Catalogue Number: 06E50-68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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, 1163-96; PRSM NEXT RFRB IN, 06A36-11, 1163-96
• Patient Sex: Unknown