MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M HBV AMPLIFICATION KIT; HEPATITIS VIRAL B DNA DETECTION

Model Number	08N47-095
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the customer data review of the investigation and an hbv carryover study performed, a product deficiency was identified; therefore, the complaint was dispositioned as confirmed.Specification not met: the product requirement of the alinity m hbv amp kit (list 08n47) should only have a sample carryover rate (upper bound of the two-sided 95% confidence interval) of less than or equal to 2% for negative specimens tested adjacent to high positive specimens.The result (combined rate of carryover contamination was 7.95%) from the hbv carryover study, does not coincide with the alinity m hbv product requirements document.On february 27, 2022, a decision was made to issue a customer letter (urgent field safety notice / field correction recall) to notify customers of the issue.Fa-am-mar2022-269 was issued on march 6, 2022.It was deemed reportable per 21cfr 806 and therefore reportable under 21cfr803.Initial notification to the fda per 21cfr806 was completed on march 7, 2022.
Event or Problem Description
Abbott has received reports of misquantitation high results when using the alinity m hbv amplification kit.Data analysis has determined that carryover from a well containing high titer hbv to a neighboring well is a potential contributing factor.Carryover events may cause not detectable or low level quantitation samples that are positioned near high titer positive samples in the assay tray to produce falsely elevated (misquantitation high) hbv results.A product deficiency was identified for the alinity m hbv assay.The potential hazard associated with this issue is incorrect results (misquantitation high).Field action (fa-am-mar2022-269), was taken to address this issue.It was deemed reportable per 21cfr806 and therefore reportable under 21cfr803.
Additional Manufacturer Narrative
The sample carryover data for the alinity m hbv assay was recalculated per communications with the fda which resulted in a change of the overall carryover rate from(b)(4) to(b)(4) this change was reflected in the associated risk assessment.Initial notification to the fda regarding the updated field action notice was completed on november 4, 2022.Updates to the associated customer letter (urgent field safety notice / field correction recall) fa-am-mar2022-269 are in process, with input from fda, to provide customers this updated carryover rate.

• Brand Name: ALINITY M HBV AMPLIFICATION KIT
• Common Device Name: HEPATITIS VIRAL B DNA DETECTION
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: sarah parker ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2243617355
• MDR Report Key: 13943851
• Report Number: 3005248192-2022-00527
• Device Sequence Number: 4932922
• Product Code: MKT
• UDI-Device Identifier: 00884999047754
• UDI-Public: 00884999047754
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P200013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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 Model Number: 08N47-095
• Device Catalogue Number: 08N47-95
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005248192-03/07/22-001C
• Patient Sequence Number: 1
• Patient Sex: Unknown