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

Catalog Number	03L68-68
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product recall letter was issued to all prism customers who have received prism hiv o plus assay kit, list number 03l68-68, lot number 83104m500.The letter informs the customer of the issue regarding the potential for calibration failures due to the group o positive assay control (opc) exceeding the prism software sample to cutoff (s/co) upper specification.The letter instructs the customer to discontinue use of the suspected lot and destroy any remaining inventory.The customer is instructed that if they do not have replacement material available, they can continue to use the lot until they receive replacement material as long as their calibrator and control values meet specifications.The abbott investigation has concluded that the probable cause of the elevated group o control results is an inhibitory factor present in the recalcified human plasma component of the control diluent.This diluent was used to manufacture the (b)(6) group o (b)(6) assay control of reagent lot 83104m500.
Event or Problem Description
The customer was experiencing calibration failures due to (b)(6) group o (b)(6) assay control out of range high with abbott prism hiv o plus, list number 03l68-68 lot 83104m500.No impact to patient management was reported.

• 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: 8000961
• Report Number: 1415939-2018-00153
• Device Sequence Number: 202859
• Product Code: MZF
• UDI-Device Identifier: 00380740062958
• UDI-Public: 00380740062958
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 08/28/2018
• Device Catalogue Number: 03L68-68
• Device Lot Number: 83104M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1415939-05/29/18-001-R
• Patient Sequence Number: 1