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 Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4), has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported while testing with bd sedi-40 information is not being sent to lis.The following information was provided by the initial reporter: sedi does not send data to lis, i have checked with other analyzer for this specific lis and the other analyzer does, so i assume that there is and issue with this one: (b)(4).

Manufacturer Narrative

H.6.Investigation: instrument sedi 40 17- 42019 was returned to the manufacturer for service with respect to the reported defects ¿ noisy, broken plate, and no host communication.The instrument was evaluated by visual examination and functional testing and the reported defects were confirmed.The fan was replaced, the broken plate was replaced, and the host communication was re-established.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.H3 other text : see h.10.

Event Description

It was reported while testing with bd sedi-40 information is not being sent to lis.The following information was provided by the initial reporter: sedi does not send data to lis, i have checked with other analyzer for this specific lis and the other analyzer does, so i assume that there is and issue with this one: (b)(6).

• 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: 11314399
• MDR Text Key: 259577559
• Report Number: 2243072-2021-00313
• Device Sequence Number: 1
• Product Code: JPH
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 02/19/2021

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 Catalogue Number: 361546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1