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

Catalog Number 105118

Device Problem False Positive Result (1227)

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

Event Date 08/02/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, hologic received a report of customer getting two failed aptima trichomonas vaginalis (atv) runs on the tigris instrument to hologic technical support (ts).In addition, the customer noted multiple equivocal results in the aptima combo 2 (ac2) assay on the same instrument.Hologic requested additional logs from the customer for review.The data showed seven valid worklist where results may have been impacted by the "spiking" in the curves.The seven worklists contain ac2, (b)(6) and atv assay results.Customer was notified of the issue.Customer indicated that all valid results were reported out.Field service engineer determined the auto detect (ad) injector caused the issue.Fse repaired the instrument.Customer later reported that all of the potentially affected samples were retested and results were amended.Per risk assessment: the severity associated with a false positive result using the aptima hpv assay is serious.To mitigate this risk, hologic identified potentially impacted specimens and informed the customer.Customer retested the samples in question.The potential impact to a patient who receives a false positive result for hpv would be inconvenience, anxiety, and over-testing.If the false positive result was obtained during repeat co-testing, a colposcopy is recommended.False positive gc or ct results from the ac2 assay and false positive t.Vaginalis results from the atv assay could lead to antibiotic overtreatment as well as adverse psychosocial outcomes for the patient and his/her partner(s).Customer retested the samples in question.Per the respective package inserts (aptima hpv assay: aw-12820, rev.004; ac2 assay: 501798, rev.008; atv assay: 502246, rev.006), the results from these assays should be interpreted in conjunction with other laboratory and clinical data available for the clinician.

Manufacturer Narrative

Final mdr: field service engineer went to the customer site, repaired the instrument, and confirmed that the tigris instrument was correctly functioning.The cause of the failure is the auto detect (ad) injector.

• Brand Name: TIGRIS INSTRUMENT SYS-CD
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego 92121
• MDR Report Key: 12411479
• MDR Text Key: 280606676
• Report Number: 2024800-2021-00007
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• PMA/PMN Number: K003395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/01/2021

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: 09/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other