MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number 06P06-55

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

The customer observed (b)(6) alinity s anti-hbc results generated on an alinity s analyzer for multiple samples during october and november.The following results were provided: (b)(6).The blood banking units were discarded, and there was no impact to patient management reported.

Manufacturer Narrative

Patient identifier: (b)(6).This report is being filed on an international product, list number 06p06-55 that has a similar product distributed in the us, list number 06p06-60.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and inhouse testing of a retained kit of reagent lot 27522be00.Return testing was not completed as returns were not available.Ticket and trending review did not identify any trends for the likely cause list or lot number.Data and information provided by the customer were reviewed and support the complaint issue without indication of any additional issue.Device history record review did not identify any potential non-conformances, non-conformances, or deviations associated with the likely cause lot.Inhouse testing of a retained kit of the likely cause lot was performed.Specifications were met indicating the lot is performing as expected.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency with the alinity s anti-hbc reagent lot 27522be00 was identified.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Type of Device: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 13090482
• MDR Text Key: 286598667
• Report Number: 3002809144-2021-00722
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

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: 04/07/2022
• Device Catalogue Number: 06P06-55
• Device Lot Number: 27522BE00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)