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

Catalog Number	06D18-68
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: ANTI-HCV
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7321522
• Report Number: 1415939-2018-00031
• Device Sequence Number: 16181073
• Product Code: MZO
• UDI-Device Identifier: 00380740062996
• UDI-Public: (01)00380740062996
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: 09/13/2018
• Device Catalogue Number: 06D18-68
• Device Lot Number: 81093M500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 03/22/2018
• 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: LN 06A36-04, SN (B)(4); LN 06A36-04, SN (B)(4); PRISM 6 CHANNEL ANALYZER; PRISM 6 CHANNEL ANALYZER