MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 4ML LITHIUM HEPARIN LH SEP TUBES; BLOOD COLLECTION TUBES

Model Number 454008P

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

No samples were received for evaluation.We have no further inventory of the material/batch.A check of quality records shows no deviations related to the reported event.The complaint cannot be determined.

Event Description

Customer advised they are experiencing intermittent occurrences of elevated potassium.They have been running specimens on two analyzers to see if it was an issue with the analyzer but the elevated results are the same on both analyzers.All collections are different phlebotomist from different areas of the hospital.Re-draws are all within normal range.The centrifuge is a statspin express 2 with the horizontal spin for flat gel separation.Centrifuge speed is checked every 6 months and spins at 8500 rpm (4400g).Gel barriers are properly formed with no sign of cells leaking into the plasma.Plasma is not hemolyzed.Customer advises they follow proper phlebotomy practices.They are a stat lab so tubes go into centrifuge within 5 minutes of draw but they do not have a pneumatic tube system.

• Brand Name: VACUETTE 4ML LITHIUM HEPARIN LH SEP TUBES
• Type of Device: BLOOD COLLECTION TUBES
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer (Section G): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617800
• MDR Report Key: 10829500
• MDR Text Key: 252287557
• Report Number: 1125230-2017-00009
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960857
• 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: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 454008P
• Device Catalogue Number: 454008P
• Device Lot Number: B170134S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1