MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HIV O PLUS; HIV-1 AND HIV-2 ANTIBODIES

Catalog Number	03L68-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed (b)(6) results on the prism analyzer.The following data was provided: sample (b)(6): tested on (b)(6) 2018.(b)(4) lot 87090m500, exp 1/9/2019.(b)(6).Per the package insert: repeatedly (b)(6) results indicate the presence of (b)(6) by the criteria of the abbott prism hiv o plus assay.There was no impact to patient or donor management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, review of field data and review of specificity testing results.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Clinical specificity was reviewed in the prism metrics database through review of initial reactive (ir) and repeat reactive (rr) of the total donor population which comprises both serum and plasma samples.Specificity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: PRISM HIV O PLUS
• Common Device Name: HIV-1 AND HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7894766
• Report Number: 1415939-2018-00135
• Device Sequence Number: 19424677
• Product Code: MZF
• UDI-Device Identifier: 00380740062958
• UDI-Public: 00380740062958
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 01/30/2019

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: 01/09/2019
• Device Catalogue Number: 03L68-68
• Device Lot Number: 87090M500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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: 1416, 1425, 1389, 1342, 1267, 1424; 1416, 1425, 1389, 1342, 1267, 1424; PRISM LN 06A36-04; PRISM LN 06A36-04; SN (B)(4); SN (B)(4)