MAUDE Adverse Event Report: ABBOTT LABORATORIES 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

Patient identifier: sid (b)(6).This issue was previously reported under mdr number 3002809144-2019-01059.Under the same suspect medical device but an incorrect manufacturer name, city and state.The evaluation of complaint data for the product and likely cause prism (b)(6) 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.

Event Description

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

• Brand Name: ABBOTT PRISM HBCORE
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10308776
• MDR Text Key: 241374681
• Report Number: 1415939-2020-00101
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1