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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false positive (b)(6) results on the prism analyzer.Twenty-seven (27) results were repeat reactive and confirmed negative on nat.There was no impact to patient management reported.
Additional Manufacturer Narrative
Two additional suspect medial devices were added on 07jan2020.Lot 04127m700 is documented in manufacturers report 1415939-2020-00005 lot 05046m700 is documented in manufacturers report 1415939-2020-00006 an evaluation is still in process.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within expected limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Additional Manufacturer Narrative
An error was identified on february 13, 2020.The incorrect product code of mzo (section d.2b) was used in the previous submissions.The correct code is qhm, this report is being submitted to correct the product code.No further changes or corrections to the product information or evaluation are needed.

• 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: 9560085
• Report Number: 1415939-2020-00004
• Device Sequence Number: 2483078
• Product Code: QHM
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2020

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: 05/28/2020
• Device Catalogue Number: 06D18-68
• Device Lot Number: 06088M700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/11/2020; 02/13/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/08/2020; 02/11/2020; 02/24/2020
• 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: 1336, 1238, 1173, 1382, 1239; 1336, 1238, 1173, 1382, 1239; 1336, 1238, 1173, 1382, 1239; 1336, 1238, 1173, 1382, 1239; PRISM ANALYZERS LN 06A36-04; PRISM ANALYZERS LN 06A36-04; PRISM ANALYZERS LN 06A36-04; PRISM ANALYZERS LN 06A36-04; SNS 1267, 1410, 1381,; SNS 1267, 1410, 1381,; SNS 1267, 1410, 1381,; SNS 1267, 1410, 1381,