MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 2ML K2 K2EDTA 13X75; EVACUATED BLOOD COLLECTION TUBE

Model Number 454428

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Received 37 tubes 454428/b171235a for evaluation.Received customer data.We have no further inventory of the material/batch.The complaint is confirmed.We have already performed an investigation and recommend the use of lithium heparin tubes for ammonia analysis.Edta tubes according to greiner ifu are for routine immunohematology testing, rh typing and antibody testing, viral marker testing, and testing plasma in molecular diagnostics.

Event Description

Customer states that ammonia results, during a product verification study, were biased high when compared to the control tubes (bd).The study was done with staff volunteers, five volunteers per each study.Once collected, specimens were refrigerated until all volunteers were drawn.Customer estimated 20 minutes for collection of all volunteers.Specimens were centrifuged at 4000rcf for 3 minutes using statspin.After centrifugation, specimens were immediately aliquoted into "tea" (analyzer) cups and placed on the instrument.Customer did not randomize the draws per study, however specimens were drawn first in the bd tubes and first in the greiner tubes in the first and second studies respectively.Customer ran the ammonia on roche c502.Customer advised they follow the assay package insert.

Manufacturer Narrative

Manufacturer's narrative: we could not obtain a date of event.The mdr is submitted retrospectively.Corrected data: checked notification in h7 was removed, notification was entered erroneously.Additional statement to manufacturer's narrative.

• Brand Name: VACUETTE 2ML K2 K2EDTA 13X75
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 10770982
• MDR Text Key: 228958559
• Report Number: 1125230-2018-00012
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K971236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2019
• Device Model Number: 454428
• Device Catalogue Number: 454428
• Device Lot Number: B171235A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1