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	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.B3.The date received by manufacturer has been used for this field.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 occurred on patient sample and no injuries or treatment have been reported.The following information was provided by the initial reporter: the exact date is no longer traceable by the customer, but was confirmed to have occurred within (b)(6) 2024.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.
Event or Problem Description
It was reported that while using bd multitest¿, erroneous results occurred on patient sample and no injuries or treatment have been reported.The following information was provided by the initial reporter: the exact date is no longer traceable by the customer, but was confirmed to have occurred within june2024.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.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: h.6 imdrf annex b: b21.H.6 imdrf annex c: c21.H.6 imdrf annex d: d16.
Event or Problem Description
It was reported that while using bd multitest¿, erroneous results occurred on patient sample and no injuries or treatment have been reported.The following information was provided by the initial reporter: the exact date is no longer traceable by the customer, but was confirmed to have occurred within (b)(6) 2024.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.
Additional Manufacturer Narrative
H.6.Investigation summary: 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: bhr review a showing acceptable performance.Retain sample testing showing acceptable performance.Potential cause for customer reported complaint was not determined.

• 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: 19841242
• Report Number: 3008352382-2024-00003
• Device Sequence Number: 12411736
• Product Code: GKZ
• UDI-Device Identifier: 00382903371662
• UDI-Public: (01)00382903371662(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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2025

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: 06/28/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 01/07/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/27/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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