MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER INSTRUMENT; IN-VITRO DIAGNOSTIC

Model Number	COMMON
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, customer contacted hologic regarding an increased positive rate and discrepant results produced by the fusion sars-cov-2, fusion adv/hmpv/rv (amr), fusion paraflu, and fusion flu a/b/rsv assays initially ran on panther sn 03517.The customer retested samples on a different platform for sars-cov-2 and on the panther fusion for fusion flu, amr, and paraflu which produced several discrepant results.
Additional Manufacturer Narrative
The reported event that happened on (b)(6) 2022 involved respiratory and sars-cov-2 ldt assay on the same panther instrument sn: (b)(4) was a second contamination event on the same customer site.Cpt- (b)(4) was initiated to document the second contamination event.Under cpt-(b)(4) it was found that the sample shield on board was warped reducing the pipettor clearance of the shield resulting in potential contact occurring between the shield and the sample tip.Customer confirmed that no warped sample shields were identified during the 1st contamination event.Hologic field application specialist (fas) noted that environmental contamination could potentially be caused from not changing gloves and samples being in contact with clean reagent prep areas.The post-cleaning environmental run resulted in no further indication of contamination.Hologic determined that panther sn: (b)(4) is no longer contaminated.Hologic also recommended refresher and proficiency training for the panther fusion system in the laboratories to ensure the efficacy of the system and operator expertise.

• Brand Name: PANTHER INSTRUMENT
• Common Device Name: IN-VITRO DIAGNOSTIC
• 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: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584108506
• MDR Report Key: 15581997
• Report Number: 2024800-2022-01098
• Device Sequence Number: 17637099
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K171963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

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 Model Number: COMMON
• Device Catalogue Number: 902615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown