MAUDE Adverse Event Report: GREINER BIO-ONE GMBH MINICOLLECT TUBE 0.25 / 0.5 ML K2E K2EDTA LAVENDER CAP; CAPILAARY BLOOD COLLECTION TUBE

Model Number 450532

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4) we have no further complaints for this material/batch.We forwarded the complaint to our affiliated headquarters in (b)(4) from which we receive this product.According to their comments, minicollect tubes can be threaded into a premium carrier tube.This combination corresponds to the dimensions of a standard 13x75mm tube.The complete version, which is already irreversibly assembled with the carrier tube, is particularly designed for automated analysis of the sample (e.G item no.450547).In addition, these assembled tubes are primary tubes.Blood collection and analysis can be carried out in the same tube.It is not necessary to transfer the sample material in a secondary tube for analysis.The complaint is not justified.

Event Description

Customer states item does not work on instrumentation.Customer states "the lab is putting the samples (from 450532) into item 450547 after received in the other tube (450532) to run the specimen.This handling could lead to potential deviation in analytical results.

• Brand Name: MINICOLLECT TUBE 0.25 / 0.5 ML K2E K2EDTA LAVENDER CAP
• Type of Device: CAPILAARY BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller str. 32; kremsmuenster, upper austria 4550 ; AU 4550
• 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: 11269402
• MDR Text Key: 232183533
• Report Number: 8020040-2021-00005
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182078
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 450532
• Device Catalogue Number: 450532
• Device Lot Number: A20063DD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• 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