MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA CMV QUANT ASSAY; CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY

Model Number	CMV KIT, APTIMA, IVD
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : other.
Event or Problem Description
On (b)(6)2023, the customer called in a complaint regarding ml2 errors with the aptima cmv quant assay; however, the details of how patients could potentially be affected were not communicated.During follow-up with the customer on (b)(6)2023 (awareness date), hologic became aware of that the customer submitted an mdr; however, the customer did not share the details of the mdr.On (b)(6)2023, hologic received the mdr report from the fda.In that notification, the customer indicated that they have experienced errors on the hologic panther fusion platform that led to multiple sample failures when using the aptima cmv quant assay.As a result of the errors, the customer indicated that recollection of the plasma specimens is required and that there is a delay in cmv results.The customer indicated that this is of significant consequence to transplant recipients that are undergoing serial cmv monitoring.As the customer indicated, hologic is working on a solution and will continue to investigate this issue.Hologic is in process of writing risk assessment based upon the information provided by the customer.
Event or Problem Description
Follow-up report.See section h10.
Additional Manufacturer Narrative
The following is a resubmission that was initially submitted as a follow up mdr (2024800-2023-00012) on 07/28/2023 by hologic.The customer reported dissatisfaction with the aptima cmv quantitative assay and filed a medwatch report (key mw5118218) due to the delays in cmv assay results.The customer indicated that they have experienced ml2 error flags on the hologic panther fusion platform that led to the recollection of plasma specimens and a delay of cmv test results by several days.The customer indicated that this could be of significance for transplant recipients undergoing serial cmv monitoring.Of note, the ml2 error flag is only associated with invalid results and hologic was not made aware of any patient harm, adverse event or serious injury associated with this reported issue.Furthermore, hologic was not made aware of any treatment provided or withheld.Hologic completed an investigation and determined that the root cause of this reported issue is related to the processing of specific patient plasma specimens that generally have abnormally high globulin concentrations.There was no indication that the customer¿s panther fusion instrument was not working as intended.Hologic completed a risk assessment regarding ml2 error flags.The investigation performed by hologic indicated that the overall ml2 error flag rate was approximately 0.5%.Based on the risk assessment, for most patients, invalid cmv results would have minimal impact to the patient.According to an infectious disease medical doctor consulted by hologic, it is estimated that approximately 1 in 1,000 patients may be negatively impacted due to a multiple day delay in cmv results.Thus, in combination with the overall failure rate of (b)(4), there is a remote probability (approximately 5 in a million patient samples tested) a patient may be impacted by a multiple day delay in cmv results.Additionally, a benefit/risk analysis was performed and reviewed by the infectious disease medical doctor.It was concluded that the benefits for continued availability of the aptima cmv quant assay outweigh the risks to patients.
Event or Problem Description
Follow-up report.See section h10.

• Brand Name: APTIMA CMV QUANT ASSAY
• Common Device Name: CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 17140554
• Report Number: 2024800-2023-00012
• Device Sequence Number: 18099346
• Product Code: PAB
• UDI-Device Identifier: 15420045514553
• UDI-Public: 15420045514553
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P210029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/15/2024
• Device Model Number: CMV KIT, APTIMA, IVD
• Device Catalogue Number: PRD-05074
• Device Lot Number: 310076, 402941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 06/08/2023; 06/08/2023; Not provided
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 06/30/2023; 07/28/2023; 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown