MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HIV O PLUS ASSAY KIT; HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES

Catalog Number	03L68-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
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.
Event or Problem Description
The customer observed (b)(6) results for one donor on (b)(6) 2021.The following data was provided: sid (b)(6) initial result on sn (b)(6) no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive abbott prism hiv o plus results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review on lot 23057m700 did not show any non-conformances, potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.A technical review of field data for prism hiv o plus was performed.Overall reactive rates of lot 23057m700 were collected and assessed.The reactive rate performance of lot 23057m700 observed at the customer¿s site is within the package insert representative data and comparable to the performance at the other sites and to other analyzed reagent lots.Further, the irr, rrr and specificity observed for lot 23057m700 across all available us customer sites is within package insert representative data and comparable to the reactive rate performance of other analyzed lots.Based on the investigation the abbott prism hiv o plus assay is performing as intended, no systemic issue or deficiency of the abbott prism hiv o plus assay for lot number 23057m700 was identified.

• Brand Name: ABBOTT PRISM HIV O PLUS ASSAY KIT
• Common Device Name: HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES
• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12576751
• Report Number: 1415939-2021-00036
• Device Sequence Number: 19050506
• Product Code: QHM
• UDI-Device Identifier: 00380740062958
• UDI-Public: 00380740062958
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/04/2021

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: 12/07/2021
• Device Catalogue Number: 03L68-68
• Device Lot Number: 23057M700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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, 1104-96 AND 1152-96; PRSM NEXT RFRB IN, 06A36-11, 1104-96 AND 1152-96; PRSM NEXT RFRB IN, 06A36-11, 1104-96 AND 1152-96
• Patient Sex: Unknown