MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HCV; ANTI-HCV

Catalog Number 06D18-68

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) results while using the prism hcv assay on the prism 6 channel analyzer.The customer provided the following data for a male pediatric patient: sid: (b)(6), (b)(6) 2018: prism results: initial result: (b)(6), retest results (after centrifugation): (b)(6).The specimen was also (b)(6) when tested using the ortho hcv elisa method (s/co): (b)(6), retest results: (b)(6).(b)(6) testing were each (b)(6).There has been no impact to patient management reported.

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, review of data provided by the customer, a batch record review, a search for similar complaints, and a review of product labeling.Return material was not available.A review of the customer field data indicated that the initial and repeat reactive rates are within ranges of the specificity performance listed in the prism hcv package insert for lot 81093m500.No issues were identified which would indicate a product deficiency from the batch record review.Tracking and trending review determined that there are no related adverse and non-statistical trends identified.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the prism hcv reagent, list number 6a52, lot 81093m500, was identified.

• Brand Name: PRISM HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7321522
• MDR Text Key: 102126908
• Report Number: 1415939-2018-00031
• Device Sequence Number: 1
• Product Code: MZO
• UDI-Device Identifier: 00380740062996
• UDI-Public: (01)00380740062996
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2018
• Device Catalogue Number: 06D18-68
• Device Lot Number: 81093M500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LN 06A36-04, SN (B)(4); LN 06A36-04, SN (B)(4); PRISM 6 CHANNEL ANALYZER; PRISM 6 CHANNEL ANALYZER