MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD MULTITEST¿; COUNTER, DIFFERENTIAL CELL

Catalog Number	337166
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd multitest¿ erroneous results on patient samples occurred.There was no report of user impact.The following information was provided by the initial reporter: "problem with the trucount - there seems to be too low number of beads inside, this resulted in too high absolute counting results that were not realistic." 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required): yes, wrong patient results were send to lis, where physicians had access to.One doctor contacted us, questioning the results.In other occasions we intercepted the wrong data ourselves later in the authorisation-process.2.Was there any delay of treatment due to the issue? (go to question #3): no, not that we know of.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): no samples were redrawn.The requested tests were repeated on the sample that was already available.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): not that we know of.
Additional Manufacturer Narrative
The following fields have been updated with corrected information.D.4.Unique identifier (udi) #:(b)(4).H.6 imdrf annex: b21.H.6 imdrf annex: c21.H.6 imdrf annex: d16.
Event or Problem Description
It was reported that while using bd multitest¿ erroneous results on patient samples occurred.There was no report of user impact.The following information was provided by the initial reporter: "problem with the trucount - there seems to be too low number of beads inside, this resulted in too high absolute counting results that were not realistic." 1.Are there erroneous results on patient samples from diagnostic test?(if yes or unknown, go to question #2.If no, no further questions required): yes, wrong patient results were send to lis, where physicians had access to.One doctor contacted us, questioning the results.In other occasions we intercepted the wrong data ourselves later in the authorisation-proces.2.Was there any delay of treatment due to the issue? (go to question #3): no, not that we know of.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): no samples were redrawn.The requested tests were repeated on the sample that was already available.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): not that we know of.
Additional Manufacturer Narrative
H.3.Based on the investigation results, the reported defect was confirmed, however was not replicated after retain sample testing.Investigation results that were performed on the indicated failure mode were the following: review of customer provided information.Batch history record (bhr) review showing acceptable performance.Retain sample testing showing acceptable performance.Potential cause for customer reported complaint was not determined.Bd attempted reaching out to the customer to obtain resolution.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using bd multitest¿ erroneous results on patient samples occurred.There was no report of user impact.The following information was provided by the initial reporter: "problem with the trucount - there seems to be too low number of beads inside, this resulted in too high absolute counting results that were not realistic." are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required): yes, wrong patient results were send to lis, where physicians had access to.One doctor contacted us, questioning the results.In other occasions we intercepted the wrong data ourselves later in the authorisation-proces.Was there any delay of treatment due to the issue? (go to question #3): no, not that we know of.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): no samples were redrawn.The requested tests were repeated on the sample that was already available.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): not that we know of.

• Brand Name: BD MULTITEST¿
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 19824492
• Report Number: 2647876-2024-00095
• Device Sequence Number: 8728318
• Product Code: GKZ
• UDI-Device Identifier: 00382903371662
• UDI-Public: (01)00382903371662(11)240229(17)250331(10)60469
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K060375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2024

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: 03/31/2025
• Device Catalogue Number: 337166
• Device Lot Number: 60469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 12/09/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/27/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown