MAUDE Adverse Event Report: HOLOGIC INCORPORATED PANTHER SYSTEM; IN-VITRO DIAGNOSTIC, PRODUCT CODE: NSU

Catalog Number 902615

Device Problems Misassembled (1398); Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 08/30/2017

Event Type  Injury  

Event Description

During a service visit at (b)(6) hospital (b)(6) ((b)(6)) on (b)(6) 2017, the high temp incubator was incorrectly replaced with an amp incubator on panther instrument s/n (b)(4).The incorrect incubator remained installed on the panther from (b)(6) 2017.Aptima combo 2® (ac2) assay was the only assay tested on the instrument during this period.The customer called hologic regarding a failing ac2 run on (b)(6) 2017.Based on troubleshooting at the customer site, and review of service records, it was identified on (b)(6) 2017 that an incorrect incubator was installed on the panther system.The incorrect incubator was replaced on (b)(6) 2017.The incorrect incubator was returned to hologic for evaluation and investigation.Based on the investigation studies completed at hologic on (b)(6) 2017, the use of the incorrect incubator resulted in suppressed assay control rlu values and at times invalid runs on the ac2 assay.Assessment finds the possibility of incorrect (false negative) test results reported and a remote probability that an incorrectly reported negative result could result in harm to patient health.

Manufacturer Narrative

Hologic investigated and determined the root cause of incorrect installation of incubator was human error.The field service engineers have been trained about the hardware differences of each incubator.All service personnel are officially retrained on the correct procedures for part replacements, and documented in hologic training system.

Event Description

During a service visit at (b)(6) hospital (b)(6) on (b)(6) 2017, the high temp incubator was incorrectly replaced with an amp incubator on panther instrument s/n (b)(4).The incorrect incubator remained installed on the panther from (b)(6) to (b)(6) 2017.Aptima combo 2® (ac2) assay was the only assay tested on the instrument during this period.The customer called hologic regarding a failing ac2 run on (b)(6) 2017.Based on troubleshooting at the customer site, and review of service records, it was identified on (b)(6) 2017 that an incorrect incubator was installed on the panther system.The incorrect incubator was replaced on (b)(6) 2017.The incorrect incubator was returned to hologic for evaluation and investigation.Based on the investigation studies completed at hologic on (b)(6) 2017, the use of the incorrect incubator resulted in suppressed assay control rlu values and at times invalid runs on the ac2 assay.Assessment finds the possibility of incorrect (false negative) test results reported and a remote probability that an incorrectly reported negative result could result in harm to patient health.

• Brand Name: PANTHER SYSTEM
• Type of Device: IN-VITRO DIAGNOSTIC, PRODUCT CODE: NSU
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 6892229
• MDR Text Key: 87301056
• Report Number: 2024800-2017-00023
• Device Sequence Number: 1
• Product Code: NSU
• UDI-Device Identifier: 2090001124
• UDI-Public: 2090001124
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/25/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 902615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2024800-9/19/2017-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other