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

Catalog Number 03L68-68

Device Problem Calibration Error (1078)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2018

Event Type  malfunction  

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.An abbott investigation is ongoing.A follow-up report will be submitted when cause is identified.

Event Description

The customer reported calibration failures due to (b)(6) control out of range high with abbott prism hiv o plus, list number 03l68-68, lot 83104m500.No impact to patient management was reported.

Manufacturer Narrative

The abbott investigation has concluded that the 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 hiv-1 group o positive assay control of reagent lot 83104m500.

• Brand Name: PRISM HIV O PLUS
• Type of Device: HIV-1 AND HIV-2 ANTIBODIES,
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7620419
• MDR Text Key: 112469272
• Report Number: 1415939-2018-00103
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00380740062958
• UDI-Public: 00380740062958
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: 03L68-68
• Device Lot Number: 83104M500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1415939-05/29/18-001-R
• Patient Sequence Number: 1
• Treatment: PRISM ANALYZER, LIST 06A36; PRISM ANALYZER, LIST 06A36; SERIAL (B)(4); SERIAL (B)(4)