MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 3ML LH LI HEP SEP NR GRN/Y 13X75; EVACUATED BLOOD COLLECTION TUBE

Model Number 454247P

Device Problems Particulates (1451); Low Test Results (2458)

Patient Problems Hemolysis (1886); Jaundice (2187)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Received 454247p: 1rk and 1pc b17103ks, 5pc b161038s, 1pc b17063kd and 2pc b17073nb (not on original complaint) for evaluation.No samples of b171033w were received.We have no further complaints on the material/batches.Samples were tested, according to gbo standard testing procedures, with regards to correct assembly, level mark, filling level, draw volume and additive content according to iso 6710 'single use containers for venous blood specimen collection' and clsi gp39-a6 regulations for 'evacuated tubes and additives for blood specimen collection'.Tubes were verified to be correctly assembled and had the correct fill guide line position.Greiner fill mark provides a visual control opportunity for the phlebotomist and for the lab personnel to check for proper volume collection of specimen.Both standards specify the draw volume to be within +/- 10% range of the nominal fill volume.No visual deviation in fill volume, sporadic low or high fill, could be observed in the tested samples.All tubes tested filled within the +/-10% tolerance range.Additive content was found to be within specification in all tested samples.Samples were checked for potassium content and none could be detected.No deviations could be observed in the samples.The complaint cannot be confirmed.

Event Description

Customer states they are experiencing intermittent low calcium results.Customer identified four lot numbers, but advised that it has occurred with other lots prior.The analyzer used by customer is siemens dimension vista.After servicing the analyzer, the siemens' field service tech told the customer the issue was not with the analyzer and that the low calcium occurrence may be caused by the tube.Customer advised they are unaware of any other erroneous results occurring concurrently with the low calcium.Customer reports no hemolysis, icterus, cloudiness or particulate matter in the plasma samples.

• Brand Name: VACUETTE 3ML LH LI HEP SEP NR GRN/Y 13X75
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• 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 ; 7042617823
• MDR Report Key: 10848191
• MDR Text Key: 225125561
• Report Number: 1125230-2017-00015
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2018
• Device Model Number: 454247P
• Device Catalogue Number: 454247P
• Device Lot Number: B17103KS, B171033W, B161038S,
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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