MAUDE Adverse Event Report: BABSON DIAGNOSTICS BABSON SAMPLE PREPARATION DEVICE; CENTRIFUGES FOR CLINICAL USE

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device's behavior in this scenario is an intended design feature.It is critical for the device to prioritize preventing identity mix-up so that results are not reported to the incorrect person.Follow up training with the collection tech was provided.Additional mitigations to detect and help guide the collection tech with handling the situation is added to the next software upgrade.
Event or Problem Description
On (b)(6) 2026, customer's sample was not processed by the babson sample preparation device (spd) on order (b)(4) (sample id (b)(6)).This was discovered when a babson service team member visited the collection site on (b)(6) 2026.He found a gold sample tube, containing the customer's blood, in the caddy portion of the spd.The sample sat in the caddy overnight and had not been processed.The service team member was able to reboot the spd which restored the device to proper functionality.The customer's sample was brought back to the laboratory; however, the sample was deemed unviable and could not be processed.The customer was notified of human chorionic gonadotropin (hcg) pregnancy test not performed on (b)(6) 2026 by a betterway customer service representative.The customer was offered a recollection, which the customer accepted.On the same day (b)(6) 2026, their new sample (order (b)(4), sample id (b)(6)) was successfully collected.The hcg pregnancy test result was reported to the customer on (b)(6) 2026.No critical lab test values were detected.Customer did not report serious injury, illness, or delay in diagnosis.Upon further investigation, it was discovered that the issue is due to use error where the collection tech inserted a tube (b)(6) that was different from the tube (b)(6) they externally scanned.Scanning the tube at the time of collection is part of the 2 patient identifier process to prevent identity mix-up.The tech scanned the 1st tube (b)(6) and subsequently used a different tube for collection (b)(6).After the customer was collected with the 2nd tube (b)(6), the tech placed that tube into the spd.However, the spd would not accept the tube due to the spd's design feature which prevents processing a sample with a barcode different from the scanned sample in order to prevent identity mix-up.The spd has a safety feature prompting the tech to either accept the 2nd tube (b)(6) or insert the 1st scanned tube (b)(6), which the tech did not do on either.As a result, the spd did not process the sample.Because customer came back for recollection the same day the issue was rectified, results were reported within 24 hours with no customer adverse event.

• Brand Name: BABSON SAMPLE PREPARATION DEVICE
• Common Device Name: CENTRIFUGES FOR CLINICAL USE
• Manufacturer (Section D): BABSON DIAGNOSTICS; 1321 rutherford ln; ste 200; austin TX 78753
• Manufacturer (Section G): BABSON DIAGNOSTICS; 1321 rutherford ln; ste 200; austin TX 78753
• Manufacturer Contact: jane hughie ; 1321 rutherford ln; ste 200; austin, TX 78753 ; 5122945109
• MDR Report Key: 25017224
• Report Number: 3028019212-2026-00001
• Device Sequence Number: 13169778
• Product Code: JQC
• UDI-Device Identifier: 00850058457017
• UDI-Public: 850058457017
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female