MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD TOTALYS SLIDEPREP; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number 491346

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

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: na.

Event Description

It was reported that while using bd totalys slideprep there was increased risk of misassociation due to a use error by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that source for the specimens look different and appear to be flipped.".

Manufacturer Narrative

H.6.Investigation: complaint reports chain of custody issue on slideprep (catalog number 491346) serial number (b)(6).Complaint alleges that 2 samples have been switched, specimens look different and appear to be flipped.Customer was advised to perform a test run with colored and clear samples to identify if the samples switched.Customer reported no errors or switched samples after test run.Customer was advised the improbability of the slideprep to reverse two samples based on the how the instrument operates.Note: by design, the slideprep instrument diti utilizes safe travel lanes to prevent the accidental dispense of patient sample on to a different slide and therefore, never travels over another patient cell circle.Root cause is not determined, and this complaint is not a confirmed failure of the instrument.Dhr review revealed no abnormalities during build and test of this unit prior to shipping, as it is related to the failure mode reported.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "chain of custody." h3 other text : see h.10.

Event Description

It was reported that while using bd totalys slideprep there was increased risk of misassociation due to a use error by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that source for the specimens look different and appear to be flipped.".

• Brand Name: BD TOTALYS SLIDEPREP
• Type of Device: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12748507
• MDR Text Key: 280070275
• Report Number: 1119779-2021-01758
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: 00382904913465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 491346
• Device Catalogue Number: 491346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1