MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HBSAG CONFIRMATORY ASSAY

Catalog Number	06E51-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No customer returns were available.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 the likely cause lot.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified.Field data was reviewed regarding reactive rates for the likely cause lot.The rates were within package insert specifications.Based on the available information, no product deficiency was identified.
Event or Problem Description
The customer observed false reactive prism (b)(6) confirmatory results for 1 sample.The sample tested negative with nat testing.No impact to patient management was reported.The following data was provided: (b)(6) 2020, sid (b)(6), (b)(6) results = 6.97, 6.80, 6.91 s/co (reactive).(b)(6) results = 0.04, 0.04, 0.04 s/co (reactive).(b)(6) confirmatory: confirmed positive.

• Brand Name: ABBOTT PRISM HBSAG CONFIRMATORY ASSAY
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9940709
• Report Number: 1415939-2020-00032
• Device Sequence Number: 2968874
• Product Code: KSJ
• UDI-Device Identifier: 00380740062972
• UDI-Public: 00380740062972
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

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: 08/09/2020
• Device Catalogue Number: 06E51-68
• Device Lot Number: 07001M700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1