MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD CALIBRITE 3 BEADS; COUNTER, DIFFERENTIAL CELL

Model Number	340486
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).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 testing with bd calibrite¿ 3 beads erroneous results occurred with patient samples.Compensation was performed with all 5 calibrite boxes and the fl3 separation was 120 or less.There was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: for some time we have been having problems with the automatic analysis of the multiset, since we often had to do the manual analysis correcting the gate of beads since they were not taken in their entirety.In this last week, all the samples had to be corrected so that the gate takes all the beads acquired in the sample and the program asked us to acquire more events (once or twice in each sample).All the calibrite (5 boxes) that we have to make the compensation are from lot n °: 9277450 with an expiration date of 02/28/2021.On the current day, compensation was made with all calibrite boxes and the fl3 separation was 120 or less.For this reason, we make a claim for this batch of calibrite and for the inconvenience we have in the automatic acquisition of samples to perform the cd4 count.Are they using patient sample? yes.Was the patient treated based on erroneous results? no.Specify if any testing done was ivd or ruo lab developed test (ldt): ivd.Was there any delay of treatment due to the issue? no.Did patient samples need to be redrawn? just need a adjustment in the manual gate.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.If patient was harmed/injured, provide details - how and to what extent? no.If there was patient harm, what is the current medical status? no.
Event or Problem Description
It was reported that while testing with bd calibrite¿ 3 beads erroneous results occurred with patient samples.Compensation was performed with all 5 calibrite boxes and the fl3 separation was 120 or less.There was no patient impact.The following information was provided by the initial reporter, translated from spanish to english: for some time we have been having problems with the automatic analysis of the multiset, since we often had to do the manual analysis correcting the gate of beads since they were not taken in their entirety.In this last week, all the samples had to be corrected so that the gate takes all the beads acquired in the sample and the program asked us to acquire more events (once or twice in each sample).All the calibrite (5 boxes) that we have to make the compensation are from lot n °: 9277450 with an expiration date of 02/28/2021.On the current day, compensation was made with all calibrite boxes and the fl3 separation was 120 or less.For this reason, we make a claim for this batch of calibrite and for the inconvenience we have in the automatic acquisition of samples to perform the cd4 count.Are they using patient sample? yes was the patient treated based on erroneous results?no specify if any testing done was ivd or ruo lab developed test (ldt): ivd was there any delay of treatment due to the issue? no did patient samples need to be redrawn? just need a adjustment in the manual gate if patient samples were redrawn, was there any change or delay of treatment?no was there any physical harm/injury to the patient due to the issue?no if patient was harmed/injured, provide details - how and to what extent?no if there was patient harm, what is the current medical status?no.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00037 was sent in error.Calibrite beads are used to adjust instrument setting, and are not used on patient samples, therefore this is not considered to be a reportable malfunction.

• Brand Name: BD CALIBRITE 3 BEADS
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11244547
• Report Number: 2916837-2021-00037
• Device Sequence Number: 3433447
• Product Code: GKZ
• UDI-Device Identifier: 00382903404865
• UDI-Public: 00382903404865
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K973483
• 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
• Report Date (Section B): 03/16/2021

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: 02/28/2021
• Device Model Number: 340486
• Device Catalogue Number: 340486
• Device Lot Number: 9277450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1