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

Catalog Number 01A77-48

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 1a77 that has a similar product distributed in the us, list number 6e66.

Event Description

The customer reported a false nonreactive prism hbcore result on one donor that was reactive on the architect, cobas 8014.Nat testing = (b)(6); (b)(6); donor had previous (b)(6).No impact to donor management was reported.

Manufacturer Narrative

An error was identified on february 13, 2020.The incorrect product code of lom 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.

Manufacturer Narrative

Section a1 patient identifier sid added section d4 lot # added the evaluation of complaint data for the product and likely cause prism hbcore reagent lot 03248be00 identified normal complaint activity.No customer returns were available for evaluation.A retained kit of reagent lot 03248be00 was tested for specificity with a specificity panel and the data shows that the sensitivity performance of lot 03248be00 is not negatively impacted.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

Manufacturer Narrative

It was discovered on (b)(6)2020 that the initial emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 1415939-2020-00101 has been submitted for the correct manufacturing site and all further information will be documented under that mdr number.

• Brand Name: ABBOTT PRISM HBCORE
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9465556
• MDR Text Key: 219350174
• Report Number: 3002809144-2019-01059
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/22/2020

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 Expiration Date: 04/04/2020
• Device Catalogue Number: 01A77-48
• Device Lot Number: 03248BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 01/14/2020; 02/13/2020; 07/21/2020
• Supplement Dates FDA Received: 02/06/2020; 02/24/2020; 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM 6 CHANNEL ANALYZER LIST 06A36-04.; PRISM 6 CHANNEL ANALYZER LIST 06A36-04.; PRISM 6 CHANNEL ANALYZER LIST 06A36-04.; PRISM 6 CHANNEL ANALYZER LIST 06A36-04.; SERIAL (B)(6).; SERIAL (B)(6).; SERIAL (B)(6).; SERIAL (B)(6).