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

Catalog Number	06D18-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false repeat reactive abbott prism hcv results on eleven samples that were negative by nat testing on cobas.No specific data was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaint activity did not identify any trends for the prism hcv assay.A search for similar complaints determined there is a normal complaint activity for the likely cause lots.Field data was evaluated for lots 03037m700, 03109m700, and 03122m700 during the time frame week of 12/31/2017 to week of 07/07/2019.The prism hcv initial and repeat reactive rates of the complaint lots were within package insert specifications.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lots did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the prism hcv assay 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: 8769188
• Report Number: 1415939-2019-00130
• Device Sequence Number: 19467833
• Product Code: MZO
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/23/2019

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 Expiration Date: 03/19/2020
• Device Catalogue Number: 06D18-68
• Device Lot Number: 03122M700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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: LIST 6A36-04; LIST 6A36-04; PRISM 6 CHANNEL ANALYZER, SERIAL (B)(4); PRISM 6 CHANNEL ANALYZER, SERIAL (B)(4)