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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD ESR BI-LEVEL QC MATERIAL (4X8,5ML); ESR INSTRUMENT
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BECTON DICKINSON BD ESR BI-LEVEL QC MATERIAL (4X8,5ML); ESR INSTRUMENT Back to Search Results
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 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot# 195110 was not found for the catalog number.Device expiration date: n/a.Device manufacture date: unknown.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 abnormal control occurred during use with a bd esr¿ bi-level qc material (4x8,5ml).The following information was provided by the initial reporter, "abnormal control of bottles was outside of the customer's defined 2s field.Original mail: i am writing to you regarding our bd sedi-40 device.We have recently received the new accu-sed plus controls (lot: 1945500-5).Now we have again the problem that the abnormal control (lot: 195110) is within the manufacturer's range but outside our 2s range.We have created several aliquots and mixed them well and always get a value of 42mm/hr (manufacturer's range 40-60mm/hr; target value of 50mm/hr).".
 
Event Description
It was reported that abnormal control occurred during use with a bd esr¿ bi-level qc material (4x8,5ml).The following information was provided by the initial reporter, "abnormal control of bottles was outside of the customer's defined 2s field.Original mail: i am writing to you regarding our bd sedi-40 device.We have recently received the new accu-sed plus controls (lot: 1945500-5).Now we have again the problem that the abnormal control (lot: 195110) is within the manufacturer's range but outside our 2s range.We have created several aliquots and mixed them well and always get a value of 42mm/hr (manufacturer's range 40-60mm/hr; target value of 50mm/hr).".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 5/13/2020.H.6.Investigation: bd received samples from the customer facility for investigation.The samples were sent to elitech as they are the manufacturer for this product.Elitech's response and results can be seen below: we have investigated and have identified a few similar complaints on abnormal control lot 195110.The complaints described low results after day one of use.Collectively, complaints associated with this lot are very low compared to the amount of total abnormal controls distributed (approximately 20,000 vials per lot).Egi will continue to monitor such complaints and react accordingly based on the appropriate risk assessment.We have notified the manufacturer of the concerns about low values and samples from this lot were also taken to the manufacturer for testing.The manufacturer was not able to replicate poor results and did not determine the controls to be defective.At this time, egi, logan cannot conclusively determine why some of the abnormal controls are failing in the field or giving low results.Egi will continue to monitor such complaints and react accordingly based on the appropriate risk assessment.
 
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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 Key9982671
MDR Text Key189152643
Report Number2243072-2020-00636
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/15/2020
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 Number361555
Device Lot NumberSEE. H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Initial Date Manufacturer Received 04/01/2020
Initial Date FDA Received04/21/2020
Supplement Dates Manufacturer Received04/01/2020
Supplement Dates FDA Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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