MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD TRUCOUNT¿ TUBES; COUNTER, DIFFERENTIAL CELL

Model Number 340334

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd trucount¿ tubes that there were erroneous results.The following information was provided by the initial reporter: the laboratory reports to clinical specialist d.T.On thursday, october 13 at 4:54 p.M.Via email, which the user s.C.V.Found inside a new bag of trucount tubes included in the multitest kit (catalog 340491) at the time of assembling the multitest for t lymphocytes with patient samples on (b)(6) 2022., lot 2152075, with expiration date 31 mar 2024), seven (7) tubes with the lyophilized pearls at the bottom of the tube visibly smaller than usual.Even in some tubes, the pearl pellet was observed outside the metal grid that contains them.Under normal conditions and according to what is taught by our clinical specialists in the training given, these tubes should not be used to carry out the test.However, the user explains that the tubes were used because they did not have units available in the laboratory due to a delay in the arrival of the order and due to the need to assemble the samples that day.Of the 7 tubes, two samples had to be repeated later because beads were not observed in the plots displayed in the bd facscanto software.From the other 5 samples they did obtain the data, which, according to the user s.C.V., correlated with the clinical history and therefore were approved by the laboratory.In a telephone conversation today and through data sent via email, the user s.Mentions that the incubation temperature of the tubes in the laboratory is between 2 and 8°c, which is the first time that this event has occurred and that there are still 10 new boxes left from that same catalog and batch of the multitest t kit.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Pma / 510(k)#: k970836, k090967, k980858, k971205, k971110, k970326, k970742, k071143.

Manufacturer Narrative

H.6 investigation summary scope of issue: the scope of the complaint (b)(4) for catalogue 340334 batch 2152075, trucount absolute counting tubes us ivd - small pearl.Problem statement: customer (b)(6) reported a complaint on 14oct 2022 trucount absolute counting tubes us ivd - small pearl.Manufacturing defect trend: product 340334 (trucount absolute counting tubes, ivd) lot 2152075 was assembled in bdb san jose ca (plant 1149), using pouched subassembly 91-0786 (pouched absolute count tubes) batch 22103 manufactured in bdb cayey (plant 1157) using 91-0195 pellet lot 1340906 zero (0) non-conformance (qn) was found or reported in evaluated bhr record for subassembly 91-0786 (pouched absolute count tubes) batch 22020 and 91-0195 pellet lot 1340906 evaluated period of 14 oct 2021 to 14 oct 2022.Batch history record ( bhr) review: bhr for product 340334 (trucount absolute counting tubes, ivd) lot 2152075 and the subassembly used to manufacture 91-0786 lot 22103 were reviewed.No critical defect was identified during manufacture.The materials met all the manufacturing specifications prior to release.Complaint history review: there are six (6) additional related complaints reported for material 340334 in the period of 14oct2021 to 14oct 2022.Retain sample analysis: the retain sample for the subassembly part of material 340334 batch 2152075 ( part 91-0786 lot 22103 ) was physically evaluated and no small pellets were observed.All pellets were smooth, spherical and rolled around evenly.None was over the retainers.Returned sample: the photo provided by the customer was evaluated and defect in known and according to fmea-truc-18030 rev.4, the defect small pellet observed by the customer (pellet not under retainer) the potential causes of failure can be defect on retainers and pellet (dimension, too small) room rh out of specification.The controls established per fmea were evaluated and the subassembly material 91-0786 batch 22103 complied with all bdb requirements established.In addition, the process include an automatic machine vision system to detect small pellets, multiple pellets or pellet fragment or crushed in addition a 100% visual inspection that is performed to detect these defects per device record.Furthermore, pi 23-3483 rev 15 indicates use of the tubes: use tubes within1 hour after removal from the foil pouch and do not use beyond the expiration date indicated on the packaging.However customer acknowledges the use of trucount with small pellets." investigation reveals subassembly process of 91-0786 batch 22103 occurred under established controls, without discrepancies or deviations.The claim is not confirmed as related to the manufacturing process.The return sample was not requested to be returned because the customer provided photos and the retention sample was available, for visual inspection, at the manufacturing site and the defect was unconfirmed.Risk review: risk analysis for reported claim was performed by reviewing "bd trucount tubes risk analysis" (b)(4) , revision 03.Hazard(s) identified? yes hazard id: 3.1.10 hazard: functional hazard cause: the bead pellet within trucount tube is broken, missing, misshapen, or misplaced.Harmful effects: delay in results and customer annoyance residual severity: 2 residual probability : 1 residual risk index: 10 potential root cause : base on the investigation results the root cause was not determined.Conclusion: based on the investigation result, complaint was not confirmed.Investigation results/analysis: the investigation was performed and based on the review of complaint trend, defect trend, bhr, and risk analysis, the claim was not confirmed.Conclusion: based on the investigation result, complaint was not confirmed.

Event Description

It was reported that while using the bd trucount¿ tubes that there were erroneous results.The following information was provided by the initial reporter: the laboratory reports to clinical specialist (b)(6).On thursday, october 13 at 4:54 p.M.Via email, which the user (b)(6) found inside a new bag of trucount tubes included in the multitest kit (catalog 340491) at the time of assembling the multitest for t lymphocytes with patient samples on (b)(6) 2022., lot 2152075, with expiration date 31 mar 2024), seven (7) tubes with the lyophilized pearls at the bottom of the tube visibly smaller than usual.Even in some tubes, the pearl pellet was observed outside the metal grid that contains them.Under normal conditions and according to what is taught by our clinical specialists in the training given, these tubes should not be used to carry out the test.However, the user explains that the tubes were used because they did not have units available in the laboratory due to a delay in the arrival of the order and due to the need to assemble the samples that day.Of the 7 tubes, two samples had to be repeated later because beads were not observed in the plots displayed in the bd facscanto software.From the other 5 samples they did obtain the data, which, according to the user (b)(6)., correlated with the clinical history and therefore were approved by the laboratory.In a telephone conversation today and through data sent via email, the user s.Mentions that the incubation temperature of the tubes in the laboratory is between 2 and 8°c, which is the first time that this event has occurred and that there are still 10 new boxes left from that same catalog and batch of the multitest t kit.

• Brand Name: BD TRUCOUNT¿ TUBES
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15756111
• MDR Text Key: 307023437
• Report Number: 2916837-2022-00331
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903403349
• UDI-Public: 00382903403349
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 340334
• Device Catalogue Number: 340334
• Device Lot Number: 2152075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1