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

Catalog Number 105118

Device Problem Volume Accuracy Problem (1675)

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

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Final mdr: hologic field service engineer further evaluated this issue to determine the root cause.

Event Description

Initial and final report on (b)(6) 2021, a customer reported getting multiple invalid and (b)(6) results on their tigris instrument.Fse had successfully run a flashcheck during a preventive maintenance (pm) on 01/18.Hologic technical support (ts) and product application specialists (pas) reviewed the logs and runs performed from (b)(6) 2021, the timeframe before and after the pm to identify any trends in the ad system.Eleven worklists were potentially impacted including 7 aptima (b)(6) worklists, 3 aptima (b)(6) 16 18/45 (b)(6) worklists, and 1 aptima combo 2 (ac2) worklist.After reviewing the logs of the impacted runs, pas provided to the customer a list of potentially impacted samples and recommended to the customer to retest.The customer confirmed that the results of the runs from (b)(6) 2021 were reported out.Customer was instructed to refrain from running the affected instrument.Hologic field service engineer (fse) repaired the instrument and all verifications passed.Customer later confirmed that of the 47 (b)(6) samples that were recommended for retesting, 44 did not repeat with the original result and an amended report was sent to the providers.Per risk assessment, the severity associated with a (b)(6) result using the aptima (b)(6)assay is serious.To mitigate this risk, hologic requested the customer to retest the samples in question.If the patient received a (b)(6) result for (b)(6) the potential impact to the patient would be inconvenience, anxiety, and over-testing.If the (b)(6) result was obtained during repeat co-testing, a colposcopy is recommended.Customer/patient impact regarding the failed ac2 and (b)(6) runs: since the negative control samples for these runs were invalidated, all of the patient sample results were also invalidated, and results could not be reported out.The customer impact is having to retest the invalid runs and samples, which is a customer inconvenience.There is no impact to the patient results.

• Brand Name: TIGRIS INSTRUMENT SYS-CD
• 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: 11362979
• MDR Text Key: 241860443
• Report Number: 2024800-2021-00001
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K003395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2021

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: 02/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other