MAUDE Adverse Event Report: BECTON DICKINSON ACCU-SED®ESR BI-LEVEL CONTROL; ESR INSTRUMENT

Catalog Number 361555

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The reported lot# 1823500 was not found for the reported catalog number.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that accu-sed®esr bi-level control had a barcode defect in which the instrument would not recognize the barcode scanned in nor manually entered.No report of injury or medical intervention.No report of blood exposure to mucous membrane.

Manufacturer Narrative

Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other.D.8.Device single use?: no.H.3.Device returned to manufacture: no.H.6.Investigation: investigation summary: the investigation determined the barcode number (and therefore the barcode itself) for the accu-sed® normal control (level 1) of lot numbers #1823500, #1823500-1, #1823500-2 and #1823500-3 was incorrect for the monitor and bd sedi instruments.This could result in problems to enter the data for this level for these instrument types that are equipped with a qc program.Bd had initiated further investigation relating to this issue through a capa and as a result, corrective actions were implemented.A revised ifu (rev.C) containing the correct barcodes was communicated to all bd customers on (b)(6) 2018.Investigation conclusion: the customer's indicated failure mode for the barcode error was observed by bd.Further investigation activities were conducted through a capa and the most likely root cause was identified.As a result, corrective actions and procedures were implemented to mitigate further occurrences.Root cause description: the root cause was attributed to a manufacturing incident.Bd had initiated further investigation through a capa.The capa had identified the most likely root causes and corrective actions were implemented.Rationale: based on an assessment of severity and frequency, it was determined that a capa was required in order to determine the root cause associated with this issue.The investigation identified root cause(s) for this issue and corrective actions were implemented.

Event Description

It was reported that accu-sed®esr bi-level control had a barcode defect in which the instrument would not recognize the barcode scanned in nor manually entered.No report of injury or medical intervention.No report of blood exposure to mucous membrane.

• Brand Name: ACCU-SED®ESR BI-LEVEL CONTROL
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7698787
• MDR Text Key: 114679427
• Report Number: 2243072-2018-00477
• Device Sequence Number: 1
• Product Code: GKB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 361555
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other