MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD MULTI-CHECK CONTROL 2X2.5ML IVD

Model Number 340912

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using bd multi-check control 2x2.5ml ivd the cd4 events are not with in range.Patient impact was not reported.The following information was provided by the initial reporter: the customer is reporting the % of cd4 events is not within the ranges stated for this lot.

Event Description

It was reported that while using bd multi-check control 2x2.5ml ivd the cd4 events are not with in range.Patient impact was not reported.The following information was provided by the initial reporter: the customer is reporting the % of cd4 events is not within the ranges stated for this lot.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00334 was sent in error.Testing was done on controls not patient samples, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd multi-check control 2x2.5ml ivd the cd4 events are not with in range.Patient impact was not reported.The following information was provided by the initial reporter: the customer is reporting the % of cd4 events is not within the ranges stated for this lot.

• Brand Name: BD MULTI-CHECK CONTROL 2X2.5ML IVD
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11098674
• MDR Text Key: 247661036
• Report Number: 2916837-2020-00334
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903409129
• UDI-Public: 00382903409129
• Combination Product (y/n): N
• PMA/PMN Number: K961610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/02/2021
• Device Model Number: 340912
• Device Catalogue Number: 340912
• Device Lot Number: BM1220N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1