MAUDE Adverse Event Report: HOLOGIC INCORPORATED PANTHER INSTRUMENT; IN-VITRO DIAGNOSTIC

Catalog Number	902615
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer, (b)(6) hospital, contacted hologic on (b)(6) 2018 to report that they had a cap pierce failure (cpf) flag due to sample pipettor error which invalidated an aptima combo 2 (ac2) run (b)(4).The customer acknowledged that the operator was new and did not install the sample shield properly.After the customer correctly reinstalled the sample shield, the instrument processed without any errors.Patient results for the initial run were not impacted because the run was invalidated.On (b)(6) 2018, the customer contacted hologic again (b)(4) to report an increased number of ct and gc positive results on an ac2 run, which was related to the sample shield not seated properly.The operator who installed the sample shield for this run was the same operator who installed the sample shield on (b)(6) 2018.Run.Hologic recommended the customer to change the sample shield and rerun the assays.Since there was a high prevalence of positive results for the ac2 assays, the initial run results were suspect.The customer has stated that this operator will undergo additional training and has also implemented a charge person who will be reviewing results in the future.Per risk assessment, if the patient received a false positive result for ct or gc, the cdc recommends treatment for the patient is antibiotics.The potential impact to the patient would be therefore be inconvenience, anxiety, and unnecessary antibiotic use.The risk of reporting an incorrect std diagnostic result is considered serious.The samples were re-tested by the customer two days after reporting the initial results and 29 corrected results were reported to the clinicians.Hologic will work with customer to provide training to the operators on proper sample shield replacement.

• Brand Name: PANTHER INSTRUMENT
• Common Device Name: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA
• MDR Report Key: 8071864
• Report Number: 2024800-2018-00013
• Device Sequence Number: 2125059
• Product Code: LSL
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 902615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other