MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SEDI-40 INSTRUMENT; ESR INSTRUMENT

Catalog Number 361546

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

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

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 that during use of the bd¿ sedi-40 delivers very many llo and llh messages even though the tubes are full and well mixed before being inserted into the instrument.There was no report of injury or medical intervention.

Manufacturer Narrative

H.6.Investigation: investigation summary: bd had performed a technical evaluation of the customer's sedi-40 instrument.It was determined that upon evaluation, the service technician had verified that the instrument was operating within normal parameters, as documented in the instrument service report.No issues relating the customer's observation was observed.Investigation conclusion: based on evaluation of the customer's instrument, no issues were found.Root cause description: a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during use of the bd¿ sedi-40 delivers very many llo and llh messages even though the tubes are full and well mixed before being inserted into the instrument.There was no report of injury or medical intervention.

• Brand Name: BD¿ SEDI-40 INSTRUMENT
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7865449
• MDR Text Key: 119947295
• Report Number: 2243072-2018-01169
• Device Sequence Number: 1
• Product Code: GHC
• 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: 04/03/2019

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: 361546
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other