MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT 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	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple = (b)(6).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 reported (b)(6) prism hiv results on 4 donors.The results provided were: (b)(6) 2019 unit (b)(6) = 1(b)(6); on (b)(6) 2019 unit (b)(6) = (b)(6); on (b)(6) 2019 unit (b)(6) = (b)(6).On (b)(6) 2019 unit (b)(6) = (b)(6).All four samples were not confirmed with western blot.There was no reported impact to donor/patient management.
Additional Manufacturer Narrative
A review of tickets for lot 06086m700 identified normal complaint activity and no trends were identified for the product issue.Return testing was not completed as returns were not available.Historical review of overall customer field data was performed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for lot 06086m700.The irr, rrr and specificity of the lot is within package insert specifications.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the prism hiv o plus, lot 06086m700.

• Brand Name: ABBOTT 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: 9482642
• Report Number: 1415939-2019-00232
• Device Sequence Number: 297447
• 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): 01/03/2020

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: 04/08/2020
• Device Catalogue Number: 03L68-68
• Device Lot Number: 06086M700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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 NEXT ANALYZER, LN 06A36-34,; PRISM NEXT ANALYZER, LN 06A36-34,; SERIAL # (B)(6); SERIAL # (B)(6)