MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 454228P

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

Issues with patient sample not gelling/ clotting correctly.Sample was unable to be tested.Believed to be a single instance or patient interferent.Second sample on the same patient had the same issue later in the day.Additional samples reviewed and another patient from the same unit also had a similar issue with their sample.Centrifuges and all lab process checked and no issues identified.Additional sample from a patient in a different unit was discovered to have the same issue.Escalated to lab medical director for review and alternate processing plan put in place to identify if additional samples were affected.Also reviewed/ escalated with lab storeroom staff who worked with supply chain to rotate supply in the two units.Very low incidence seen from initial day in afternoon through next 3 days.Per current lab audits (still in review) two days later they had 2 patient samples affected.Lab continuing to monitor and use alternate processing to assess samples- this is one of the approved sub tubes that has been brought in.Likely the predominant lot number that is available in the storeroom or if other approved subs are available or can be brought in house.

• Brand Name: VACUETTE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 4238 capital dr; monroe NC 28110
• MDR Report Key: 13901135
• MDR Text Key: 287924057
• Report Number: 13901135
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 454228P
• Device Catalogue Number: 454228P
• Device Lot Number: B21073N6
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1