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 Consequences Or Impact To Patient (2199)
Date of Event	04/01/2017
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 an increase in repeat (b)(6) results after switching to prism (b)(6) reagent lot 74080m500 in (b)(6) 2017.The repeat (b)(6) samples were sent out for confirmatory testing and most of the results came back (b)(6).No adverse impact to patient management was reported.
Additional Manufacturer Narrative
No customer returns were available.Investigation of the customer issue included a review of the complaint text, a search for similar complaints and a review of labeling.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for lot 74080m500.Labeling was reviewed and found to be adequate.Review of field data indicates that the initial and repeat reactive rates for the abbott prism hcv reagent lot 74080m500 are less than the package insert upper 95% confidence intervals.Based on the available information, no product deficiency 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: 6767657
• Report Number: 1415939-2017-00165
• Device Sequence Number: 13825582
• Product Code: MZO
• UDI-Device Identifier: 00380740062996
• UDI-Public: (01)00380740062996(17)180116(10)74080M500
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

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: 01/16/2018
• Device Catalogue Number: 06D18-68
• Device Lot Number: 74080M500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1