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

Catalog Number	06D18-68
Medical Device Problem Code	High Test Results (2457)
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 anti-hcv results on the prism analyzer.The following data was provided: sid (b)(6) initial 1.47, repeat 1.27, 1.25 s/co, sid (b)(6) initial 1.28, repeat 1.41, 1.42 s/co, sid (b)(6) initial 1.74, repeat 1.45, 1.57 s/co.The samples were nat negative.There was no impact to patient management reported.
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.This is still a duplicate submission and the follow up and evaluation information was provided in the following related reports: lot 06088m700 is documented in manufacturers report 1415939-2020-00004 lot 04127m700 is documented in manufacturers report 1415939-2020-00005 lot 05046m700 is documented in manufacturers report 1415939-2020-00006.
Additional Manufacturer Narrative
This is a duplicate submission and is no longer needed.The follow up and evaluation information will be provided in the following related reports: lot 06088m700 is documented in manufacturers report 1415939-2020-00004 lot 04127m700 is documented in manufacturers report 1415939-2020-00005 lot 05046m700 is documented in manufacturers report 1415939-2020-00006.
Additional Manufacturer Narrative
D4) on 07jan2020 the suspect medical device lot number was provided and updated from unknown to 04127m700.The product evaluation is still in process.A follow up report will be provided when the evaluation is complete.

• 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: 9521760
• Report Number: 1415939-2019-00236
• Device Sequence Number: 2483077
• 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 Catalogue Number: 06D18-68
• Device Lot Number: 04127M700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 01/08/2020; 02/13/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/07/2020; 01/08/2020; 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: LN 06A36-04 SN (B)(6); LN 06A36-04 SN (B)(6); LN 06A36-04 SN (B)(6); LN 06A36-04 SN (B)(6); PRISM ANALYZER; PRISM ANALYZER; PRISM ANALYZER; PRSIM ANALYZER