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

Catalog Number 105118

Device Problem False Positive Result (1227)

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

Event Date 07/02/2021

Event Type  Injury  

Manufacturer Narrative

Final mdr: field service engineer went to the customer site and confirmed that the tigris instrument was correctly functioning.No repair was performed to the instrument.The cause of the delay in injection is unknown.

Event Description

Initial and final report.On (b)(6) 2021 a customer called hologic to report an aptima (b)(6) assay run with around (b)(6) from the tigris instrument.The customer reported that about (b)(6) listed (b)(6) and the remaining (b)(6) listed (b)(6).Hologic technical support (ts) and product applications specialist (pas) reviewed the logs for wl 101240 and noted that the (b)(6) samples showed a delay in auto detect (ad) injection that potentially caused incorrect results.Customer did not release results from (b)(6) wl 101240, and the samples were retested on a different instrument.However, to assess general panther performance prior to wl:101240 and current performance, logs from (b)(6) 2021 were also reviewed.Pas noted that (b)(6) wl 101239 test number (b)(6) (sid: (b)(6)) performed on (b)(6) 2021 may have been impacted.Customer confirmed that test number (b)(6) was reported out as (b)(6).On (b)(6) 2021, the customer notified ts that the sample was retested with (b)(6) on another instrument, and it resulted out (b)(6).The customer updated the patient sample to a (b)(6) result.Customer made a decision to notify their client of the updated result.The customer does not know if the patient received treatment for the (b)(6) result from wl 101239.Field service engineer (fse) went to the customer site on 07/06/2021 and confirmed that the tigris instrument is correctly functioning by running verification checks.No repair was performed to the instrument.Further evaluation by product support instrumentation (psi) noted that there may have been an issue with the ad injection system for the sample in question.However, a (b)(6) sample near the (b)(6) assay sensitivity claims could not be ruled out.The exact cause of the delay in injection is unknown.Per risk assessment, the severity associated with a (b)(6) result using the aptima (b)(6) assay is serious.To mitigate this risk, hologic identified and informed the customer.Customer retested the sample in question.The potential impact to a patient who receives a (b)(6) result for (b)(6) would be inconvenience, anxiety, and over-testing.If the (b)(6) result was obtained during repeat co-testing, a colposcopy is recommended.

• Brand Name: TIGRIS INSTRUMENT
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC INCORPORATED; 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: 12253036
• MDR Text Key: 267127593
• Report Number: 2024800-2021-00006
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2021

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 Operator: No Information
• Device Catalogue Number: 105118
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other