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	07/14/2018
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.An evaluation is in process.
Event or Problem Description
The customer experienced multiple (b)(6) results and an increase in (b)(6) rates while using prism hiv o plus reagents.The following data was provided.Sid (b)(6) (tested (b)(6) 2018 using analyzer sn (b)(4)) initial (b)(6), repeat (b)(6), western blot and nat testing were (b)(6).Sid (b)(6) (tested (b)(6) 2018) initial (using analyzer sn (b)(4)) (b)(6), repeat (using analyzer sn (b)(4)) (b)(6), western blot testing was (b)(6).Sid (b)(6) initial (tested (b)(6) 2018 using analyzer sn (b)(4)) (b)(6), repeat (tested (b)(6) 2018 using analyzer sn (b)(4)) (b)(6), western blot and nat testing were (b)(6).Sid (b)(6) initial (tested (b)(6) 2018 using analyzer sn (b)(4)) (b)(6), repeat (tested july 29, 2018 using analyzer sn (b)(4)) (b)(6), western blot testing was (b)(6).No impact to patient or donor management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined that there was normal complaint activity for lot 87091m500.Using worldwide field data, the reactive rates of the prism hiv o plus assay were evaluated at the qualtex sites with prism hiv o plus lot 87091m500 compared to other lots.It was found that at the qualtex sites and peer whole blood or plasma sites, prism hiv o plus reactive rates were within chart control limits.Initial and repeat reactive rates for prism hiv o plus lot 87091m500 at qualtex sites and respective peer sites are within or below initial reactive chart control limits and less than the prism hiv o plus reactive rate 95% upper confidence intervals.A further review of overall customer field data was performed and found that initial reactive rate, repeat reactive rate, and specificity are within package insert specifications.Labeling was reviewed and sufficiently addresses the customer's issue.No 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: 7882569
• Report Number: 1415939-2018-00133
• Device Sequence Number: 2725711
• Product Code: MZF
• UDI-Device Identifier: 00380740062958
• UDI-Public: 00380740062958
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 87091M500
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 09/17/2018
• 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: PRISM ANALYZER LN 6A36-04; PRISM ANALYZER LN 6A36-04; SN (B)(4); SN (B)(4)