MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD. BOND-III; SLIDE STAINER, AUTOMATED.

Model Number BOND-III

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 07/07/2015

Event Type  Injury  

Event Description

Leica biosystems received a complaint indicating "they lost about 30 slides don't know how many patients it was".Information from a leica field service engineer (fse), which was received by lbs (b)(4) on 17 july 2015, states that: "the customer said that there were three cases that could not be recut." on 06 august 2015, leica biosystems received the following information from the complainant "re-biopsy was not possible because all of the tumor was in the specimens we received.Because all of this tumor was lost during processing, the original poorly prepared slides had to be sent to ucsf in consultation, to see if they could make the diagnosis".On 11 august 2015, the field support specialist manager advised that "the lab seem doubtful that they will hear the results from this".Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

Preliminary investigation of this complaint has identified that slides from case pl15-14075 were run on 4 separate runs between (b)(6) 2015.Run 1905 and run 1906 completed successfully with no reported errors.Run 1868 was abandoned by the instrument due to robot errors.Run 1914 completed with indication of a possible staining impact.Based on the test performed, one (1) slide on run 1914 is likely to be a repeat of the failed run, run 1868.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

Product problem was inadvertently not checked in the follow-up #02 report.

Manufacturer Narrative

The initial 30-day report cited (b)(\6) 2015 as the date of event (mm/dd/yyyy).The actual date of event (mm/dd/yyyy) is (b)(6) 2015.The dates specified in the follow-up #02, 30-day report for run 1868 are incorrect.Run 1868 started at 23:58pm on (b)(6) 2015 rather than (b)(6) 2015 as detailed; run 1868 was abandoned by the instrument at 02:12am on (b)(6) 2015 rather than (b)(6) 2015 as detailed and a user intervened at 02:49am on (b)(6) 2015 rather than (b)(6) 2015 as stated.

Manufacturer Narrative

Run 1868, which started at 23:58pm on (b)(6) 2015, was abandoned by the instrument at 02:12am on (b)(6) 2015 due to errors associated with failed attempts to move the main robot.The instrument functioned as designed when the run 1868 was abandoned by continuing to hydrate the slides with de-ionised water until a user intervened at 02:49am on (b)(6) 2015.Manufacturer investigation attributed these errors to a covertile being out of position, which obstructed the main robot arm.The leica representative who provided on-site technical support in the investigation of this event advised that glass slides with clipped corners are used by the laboratory.The root cause of the misaligned covertile, which resulted in run 1868 being abandoned by the instrument, was considered to have been the use of clipped cornered glass slides.Section 2.6.1 of the bond user manual contains the following caution: "do not use slides with rounded or clipped corners." run 1914, which started at 11:15am on (b)(6) 2015 comprised three(3) slides.Run 1914 completed at 14:21pm on (b)(6) 2015 with error codes indicating that mixing was compromised with a possible staining impact on all slides.As unexpected events occurred during the run, the text of the processing module tab icon displayed to the user would have been red and the notification symbol would have appeared below the tray on the affected slides.Section 4.6 of the bond user manual states: "if this happens check the system status screen for attention icons and right click on them to display information about the attention state.You should also inspect the run events report (refer to 9.4 run events report) to see any other information about problems during the run." investigation by the manufacturer was unable to unequivocally determine the root cause of the compromised mixing during run 1914, which resulted in the adverse staining impact reported.

• Brand Name: BOND-III
• Type of Device: SLIDE STAINER, AUTOMATED.
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149 ; 3 9211753
• MDR Report Key: 5002807
• MDR Text Key: 22946696
• Report Number: 8020030-2015-00070
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BOND-III
• Device Catalogue Number: 22.2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR