MAUDE Adverse Event Report: BECTON DICKINSON BD ESR¿ BI-LEVEL QC MATERIAL (4X8,5ML); 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 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical device expiration date: unknown.(b)(6).Device evaluated by mfr: 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.

Event Description

It was reported that there were 2 occurrences with inaccurate results were being reported with bd esr¿ bi-level qc material (4x8, 5ml).The following information was provided by the initial reporter: the opened bsg controls give too low values when measured.

Manufacturer Narrative

H.6.Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, 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 there were 2 occurrences with inaccurate results were being reported with bd esr¿ bi-level qc material (4x8,5ml).The following information was provided by the initial reporter, translated from german to english: the opened bsg controls give too low values when measured.

• Brand Name: BD ESR¿ BI-LEVEL QC MATERIAL (4X8,5ML)
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8510910
• MDR Text Key: 147069199
• Report Number: 2243072-2019-00724
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• 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
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other