MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC PRISM NEXT ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number	06A36-11
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reported falsely repeat reactive prism anti-hcv results on multiple donors.Initial and repeat reactive rates for the anti-hcv assay increased the week ending 15jun2019 and continued through the week ending 22jun2019.Historically, hcv repeat reactive rates run 0.04% of total donors tested, with more than 50% confirming by supplemental dhcv testing.During the two weeks named above, hcv repeat reactive rates were 0.07% of total donors tested, with only 30% confirming.No impact to donor management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for increased initial and repeat reactive rates while processing abbott prism hcv with prism reaction trays, (list number 05a07-01, likely cause lot# 03018m700), identified normal complaint activity.No customer returns were available for evaluation.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lots.This review did not identify any non-conformances, potential non-conformances or deviations.A review of overall customer field data was performed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for prism hcv with prism tray lot 03018m700.The irr, the rrr and the specificity of the lot is within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the prism tray lot 03018m700.

• Brand Name: PRISM NEXT ANALYZER
• Common Device Name: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8776958
• Report Number: 1628664-2019-00481
• Device Sequence Number: 2666234
• Product Code: MZA
• UDI-Device Identifier: 00380740008420
• UDI-Public: 00380740008420
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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 Catalogue Number: 06A36-11
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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: LOT# 02036N100; PRISM HCV, LIST # 06D18-68,; LOT# 02036N100; PRISM HCV, LIST # 06D18-68,