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

Model Number	340912
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11098674
• Report Number: 2916837-2020-00334
• Device Sequence Number: 3786181
• Product Code: GKZ
• UDI-Device Identifier: 00382903409129
• UDI-Public: 00382903409129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K961610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 12/03/2020; 06/21/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/09/2021; 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1