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

Model Number 09N78-085

Device Problem Unable to Obtain Readings (1516)

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

Event Date 08/08/2022

Event Type  malfunction  

Event 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.

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 eua200572, 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, 3005248192-2022-00948, 3005248192-2022-00949, 3005248192-2022-00950, 3005248192-2022-00951, 3005248192-2022-00952, 3005248192-2022-00953, 3005248192-2022-00954, 3005248192-2022-00956, 3005248192-2022-00957, 3005248192-2022-00958, 3005248192-2022-00959, 3005248192-2022-00960, 3005248192-2022-00961, 3005248192-2022-00962, 3005248192-2022-00963, 3005248192-2022-00973.

• Brand Name: ALINITY M SARS-COV-2 CONTROL KIT
• Type of Device: 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: 15736501
• MDR Text Key: 307584059
• Report Number: 3005248192-2022-00974
• Device Sequence Number: 1
• Product Code: QJR
• UDI-Device Identifier: 00884999049208
• UDI-Public: 00884999049208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3005248192-08/19/22004R
• Patient Sequence Number: 1