MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M SARS-COV-2 CONTROL KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number	09N78-085
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation confirmed a deficiency where internal control failures due to error code 9186 (internal control failed), for alinity m sars-cov-2 control kit (list: 09n78-085) lot: 530738, is higher than expected when compared to historical control lot performance.Urgent field safety notice / field correction recall (fa-am-aug2022-279) was issued on august 19, 2022 to address this issue.The field action was reported to the us fda in alignment with the conditions of authorization contained in the associated letter of authorization for the alinity m sars-cov-2 assay eua (list: 9n78).This action was communicated to the fda on august 19, 2022.This mdr is being submitted in alignment with the requirements in the letter of authorization of the alinity m sars-cov-2 eua: (b)(4), section iv, condition g that abbott molecular will report to fda any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the product of which we become aware.The following mdrs were also reported as related to fa-am-aug2022-279: 3005248192-2022-00766, 3005248192-2022-00767, 3005248192-2022-00768, 3005248192-2022-00769, 3005248192-2022-00770, 3005248192-2022-00771, 3005248192-2022-00772, 3005248192-2022-00773, 3005248192-2022-00774, 3005248192-2022-00775, 3005248192-2022-00777, 3005248192-2022-00778, 3005248192-2022-00780, 3005248192-2022-00947.
Event or Problem Description
The complaint investigation determined a product deficiency for alinity m sars-cov-2 control kit (list: 09n78-085) lot: 530738.Complaint ticket documents internal control failures due to error code 9186 (internal control failed), for alinity m sars-cov-2 control kit (list: 09n78-085) lot: 530738, is higher than expected when compared to historical control lot performance.Alinity m sars-cov-2 ctrl kit part: 09n78-085 contains a positive control (pc) and a negative control (nc).One replicate each of the positive and negative control must be valid for the run to be valid.Error code 9186 (internal control failed) invalidates the control sample, and therefore invalidates the run if there is no other valid control.The system will not schedule any new tests when the qc status is invalid.There is no impact to patient samples as the samples are processed independently of the negative control/positive control.There is no potential for incorrect results.This issue may potentially cause a delay in results.

• Brand Name: ALINITY M SARS-COV-2 CONTROL KIT
• Common Device Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• 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: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315
• MDR Report Key: 15716172
• Report Number: 3005248192-2022-00948
• Device Sequence Number: 5126829
• Product Code: QJR
• UDI-Device Identifier: 00884999049208
• UDI-Public: 00884999049208
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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 Expiration Date: 05/27/2023
• Device Model Number: 09N78-085
• Device Catalogue Number: 09N78-85
• Device Lot Number: 530738
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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: 3005248192-08/19/22004R
• Patient Sequence Number: 1
• Patient Sex: Unknown