MAUDE Adverse Event Report: HOLOGIC, INC TOMCAT INSTRUMENT; SAMPLE TRANSFER SYSTEM

Catalog Number ASY-07379

Device Problems Device Stops Intermittently (1599); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2017

Event Type  malfunction  

Event Description

The customer, (b)(6) called to report they observed that their tomcat instrument, sn (b)(4) sometimes fails to finish processing samples due to the e18-excessive sample volume error.This issue has been identified on two other instruments (sn (b)(4)), however, no incorrect results have been reported to hologic on either instrument.Investigation identified the instrument sent the sample pipettor to the [?]home' position in the incorrect z-axis location.This occurs when there is low friction within the x-axis, allowing the x-axis to move when the table or instrument is jolted.The effect of the sample pipettor arm moves approximately 10 mm lower than expected in the z-axis.This results in disposable tip of the pipettor making physical contact with the mucoid shelf during sample processing.Although there have been no reported incorrect results, this may lead to possible contamination of the current sample in process.In addition, the collision of the sample pipettor with the mucoid shelf may cause an unspecific amount of sample to release from the pipettor tip and disperse randomly around the instrument.This could also cause possible contamination of additional samples.Tomcat is a general purpose instrument.

Manufacturer Narrative

This is the final report as a follow-up to mfr report # 2024800-2017-00010: hologic's investigation was finalized and determined the root cause to be during the pipettor homing sequence, where the x-axis position is not held at the end position.On instruments with very low friction within the x-axis, the x-axis can continue to move when jolted by either an external source or by the instrument's own x-axis movement.Hologic's risk assessment was completed on 07jun2017.Per the assessment, there is a risk of false positive results due to potential sample cross-contamination as a result of the collision of a tip filled with positive sample with the mucous shelf.The mucous shelf can be contaminated upon collision with a tip filled with positive sample.In turn, negatives samples thereafter are in risk of cross-contamination if a subsequent tip filled with negative sample likewise impacts the contaminated mucous shelf prior to transfer into the corresponding sample tube.Or a tip filled with positive sample collides with the mucous shelf and ejects a specified amount of positive sample within the sample processing of the instrument (where the clean tips are located).The risk assessment concluded that the risk of a false positive result in the ac2, act, agc, atv, hpv-gt, and hpv assays, is assessed as minor as the diagnosis could result in temporary injury such as unnecessary antibiotics, emotional trauma, and/or inconvenience.There is a risk of false negative results due to potentially insufficient sample volume transferred into the lpt tube, after a tip filled with positive sample collides with the mucous shelf and ejects sample prior to transfer into the corresponding lpt tube.The risk of a false negative result in the ac2, act, agc, and atv assays is assessed as serious and the risk of a false negative result in the hpv-gt and hpv assays is elevated to critical as untreated infection could lead to cancer.However, based on the probability, there is a 1 in 1,760,958 (95% probability) for any tomcat in the field to result in a false negative and for any individual tomcat, the probability is 1 in 180,498 (95% confidence) to give a false negative.As a corrective action, hologic released a new software version that would prevent movement of the pipettor that would cause the incorrect homing.Hologic field service engineers (fse) are in process of updating software for each tomcat instruments.

Event Description

This is a follow-up report to mfr report # 2024800-2017-000010.The customer, (b)(6), in usa called to report they observed that their tomcat instrument, sn (b)(4) sometimes fails to finish processing samples due to the e18-excessive sample volume error.This issue has been identified on two other instruments (sn (b)(4) and (b)(4)), however, no incorrect results have been reported to hologic on either instrument.Sn (b)(4) was identified later as part of the investigation.Investigation identified the instrument sent the sample pipettor to the 'home' position in the incorrect z-axis location.This occurs when there is low friction within the x-axis, allowing the x-axis to move when the table or instrument is jolted.The effect of the sample pipettor arm moves approximately 10 mm lower than expected in the z-axis.This results in disposable tip of the pipettor making physical contact with the mucoid shelf during sample processing.Although there have been no reported incorrect results, this may lead to possible contamination of the current sample in process.In addition, the collision of the sample pipettor with the mucoid shelf may cause an unspecific amount of sample to release from the pipettor tip and disperse randomly around the instrument.This could also cause possible contamination of additional samples.

• Brand Name: TOMCAT INSTRUMENT
• Type of Device: SAMPLE TRANSFER SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 10210 genetic center dr.; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center dr.; san diego CA 92121
• Manufacturer Contact: juliette busse ; 10210 genetic center dr.; san diego, CA 92121 ; 8584108799
• MDR Report Key: 6393941
• MDR Text Key: 69872049
• Report Number: 2024800-2017-00010
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ASY-07379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention