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

Catalog Number 105118

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Final mdr.The problem in delay in injection was resolved by the hologic field service team.

Event Description

Initial and final report on 3/5/2021, a customer called hologic technical support (ts) to report that they had three invalid aptima hpv assay runs.Product application specialists (pas) reviewed the logs from (b)(6) 2021, date the instrument was last serviced to (b)(6) 2021.Pas found that eight different hpv worklists were potentially impacted by an auto detect (ad) delay.In three of the eight worklists from (b)(6) 2021 and (b)(6) 2021, an ad delay was noted to potentially impact hpv results; overall a total of 36 potential false positive hpv results occurred.Customer was informed, but customer decided to only retest the affected worklist ran on (b)(6) 2021.The customer was notified that additional logs from before (b)(6) 2021.Could be reviewed, however, the customer decided to not have those worklists reviewed and did not upload the logs.Field service engineer went to the customer site and resolve the delay in injection problem.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 (Section G): HOLOGIC INC.; 10210 genetic center drive; san diego 92121
• Manufacturer Contact: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584108506
• MDR Report Key: 11605994
• MDR Text Key: 245850173
• Report Number: 2024800-2021-00003
• 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: 04/01/2021

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: 04/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other