MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBCORE; ANTI-HBC

Catalog Number	06E66-68
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data reactive rates, and a sensitivity and specificity review.No adverse trend was identified for the issue.Labeling was reviewed and found to be adequate.Both specificity and sensitivity reviews met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Event or Problem Description
During a clinical evaluation study using prism hbcore as the predicate product, a donor specimen tested on prism was found to be discordant relative to another supplemental method being used for final result interpretation.A false non-reactive sample on the prism hbcore assay for sample w14091712311000 was identified during the course of the study.The sample tested positive on architect core-m.The donor was deferred and the blood product was destroyed; there was no impact to patient management.

• Brand Name: PRISM HBCORE
• Common Device Name: ANTI-HBC
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7824140
• Report Number: 1415939-2018-00121
• Device Sequence Number: 13820340
• Product Code: LOM
• UDI-Device Identifier: 00380740062965
• UDI-Public: 00380740062965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: 05/04/2018
• Device Catalogue Number: 06E66-68
• Device Lot Number: 80022M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1