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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported an increase in (b)(6) rates for (b)(6) results when processing on the prism.Samples were retested in duplicate and the results were (b)(6).The customer stated confirmatory testing was (b)(6).Additional testing with western blot and hiv-2 eia was also (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
This event is also being reported in manufacturer report number 1415939-2020-00007 , for a second suspect medical device.An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of the performance of the likely cause lots, a review of field data, and a review of product labeling.Evaluation of complaint data for the products and likely cause lots identified normal complaint activity.A review of the performance of the likely cause lots did not identify any nonconformances, potential nonconformances, or deviations.The review did not reveal any events or issues that may have impacted the performance in relation to the complaint issue.A review of the field data was performed which determined there is no general issue with prism hiv o plus lots 02011n100 and 05013m700.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• 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: 9485071
• Report Number: 1415939-2019-00234
• Device Sequence Number: 2372036
• 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): 01/10/2020

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: 01/07/2020
• Device Catalogue Number: 03L68-68
• Device Lot Number: 02011N100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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, LIST 06A36-04, SERIAL (B)(6)