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

Catalog Number 06D18-68

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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.

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.

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
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9521760
• MDR Text Key: 219765169
• Report Number: 1415939-2019-00236
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 06D18-68
• Device Lot Number: 04127M700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/07/2020; 01/08/2020; 02/13/2020
• Supplement Dates FDA Received: 01/07/2020; 01/08/2020; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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