MAUDE Adverse Event Report: BECTON DICKINSON BD 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 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported with the use of the bd accu-sed®esr bi-level control there was an issue with software malfunction (invalid code).There was no report of injury or medical intervention.

Manufacturer Narrative

The following field has been updated due to corrected information: describe event or problem: it was reported with the use of the bd accu-sed®esr bi-level control there was an issue with 7 instances of software malfunction (invalid code).There was no report of injury or medical intervention.Investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation activities have been conducted through a capa and the most likely root cause has been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.

Event Description

It was reported with the use of the bd accu-sed®esr bi-level control there was an issue with 7 instances of software malfunction (invalid code).There was no report of injury or medical intervention.

• Brand Name: BD 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: 7967284
• MDR Text Key: 123946350
• Report Number: 2243072-2018-01473
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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: 09/24/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other