MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 5ML LH LI HEP SEP NR GRN/Y 13X100; EVACUATED BLOOD COLLECTION TUBE

Model Number 456087P

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Received 1rk 456087p/b1904393 for evaluation.We have no further complaints on the material/batch.We have no further inventory of the material/batch.A review of quality, production, and maintenance documentation shows no deviations.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 and sodium content and none could be detected in the tested samples.Some of the samples have been evaluated in a blood draw.Gel barriers formed correctly and good separation was observed in all tested samples when centrifuging using recommended parameters within 2 hours.No critically low potassium values were observed as described by the customer.No deviations could be observed in the samples.

Event Description

Customer states there were 3 instances of critically high sodium with a critically low potassium and no other results affected.All 3 samples were from the er.When same tests were repeated on a sst drawn at the same time, sodium and potassium were normal.Example: pst results na=170 and k=2.4; sst results na=155 and k=4.2.Normal ranges: na: 135-145 mmol/l k: 3.5-5.0 mmol/l both pst and sst were run on ortho 5600.

• Brand Name: VACUETTE 5ML LH LI HEP SEP NR GRN/Y 13X100
• 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: 10833952
• MDR Text Key: 247662553
• Report Number: 1125230-2019-00015
• 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: 11/12/2020

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: 08/12/2020
• Device Model Number: 456087P
• Device Catalogue Number: 456087P
• Device Lot Number: B1904393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• 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: Unknown
• Patient Sequence Number: 1