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

Catalog Number 105118

Device Problem Insufficient Information (3190)

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

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Final mdr: customer was provide guidance on what parts on the instrument to check that may have caused the problem.The issue recovered on it's own and no further intervention was needed from hologic.

Event Description

Initial and final report on (b)(6) 2021.A customer called hologic to report two failed runs.One was an aptima combo 2 (ac2) run and another was an aptima human papillomavirus (ahpv) run.Technical support (ts) reviewed logs and confirmed a delay in auto detect (ad) that could have impacted the aptima hpv results wl 103070.However, the ad delay did not impact the ac2 assay results, as the run was invalidated.The affected run was from (b)(6) 2021.Logs from (b)(6) 2021, were requested from the customer for hologic to review any trends before and after the affected run.Hologic identified and informed the customer that there were eleven (11) potential hpv false positive samples and recommended retesting.Customer confirmed that the affected results were released, but could not confirm if treatments were provided.Customer also informed hologic that their laboratory management decided they would not retest the eleven samples since the quality control they ran was valid.Customer was provided guidance on what to check on the instrument that may have caused the problem.From log review, hologic determined that the ad issue appeared to have recovered by itself on (b)(6) 2021, and (b)(6) 2021, given that the system has produced 4 valid runs.Ts reviewed additional logs from (b)(6) 2021, and did not see ad delay.Per risk assessment, the severity associated with a false positive result using the aptima hpv assay is serious.To mitigate this risk, hologic requested the customer to retest the samples in question.If the patient received a false positive result for hpv, the potential impact to the patient would be inconvenience, anxiety, and over-testing.If the false positive result was obtained during repeat co-testing, a colposcopy is recommended.

• 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 Contact: 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 11407963
• MDR Text Key: 245850262
• Report Number: 2024800-2021-00002
• 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: 03/03/2021

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: 03/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other