MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-40; 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 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.(b)(4).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 a hardware / software malfunction for esr instrument occurred during use with a bd sedi-40.The following information was provided by the initial reporter, "it is completely or partially out of order as there is an error message "llo" in some or all positions.But if the racks are not completely full with samples, it seems to work.Error message "llo" in some or all positions.".

Event Description

It was reported that a hardware / software malfunction for esr instrument occurred during use with a bd sedi-40.The following information was provided by the initial reporter, "it is completely or partially out of order as there is an error message "llo" in some or all positions.But if the racks are not completely full with samples, it seems to work.Error message "llo" in some or all positions.".

Manufacturer Narrative

H.6.Investigation summary bd had performed a technical evaluation of the customer's sedi-40 instrument.The instrument was tested and the customer's indicated failure mode for llo error with the incident lot was not observed.Upon completion of the instrument evaluation, the service technician did find that that the plate in the tube cover was broken, but still functional and it had a noisy fan.Both parts were replaced.H3 other text : see section h.10.

• Brand Name: BD SEDI-40
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9041626
• MDR Text Key: 164596575
• Report Number: 2243072-2019-02021
• 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: 02/19/2020

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: UNKNOWN
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other