MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ PLATE TSA 5PRCT SB 90MM; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 254087

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It has been reported that the bd bbl¿ plate tsa 5prct sb 90mm has been found producing a false negative result.Confirmatory testing was performed.There was no report of patient impact.The following has been provided by the initial reporter: is a confirmatory test always performed? if we specifically test for gbs we add an ngm plate on which we will find it.But in normal clinical samples of f.E.Sputum we could miss it because the growth is similar to a enterococ.Were patient samples involved? yes.Were erroneous results reported to the clinician? we discovered this by chance so there is a chance of erroneous results but we can¿t confirm neither deny them.Were patients treated based on erroneous results? i think there is a higher chance of non-treatment because we could miss the gbs.On the tsa (254087), gbs strains grow without or with minimal hemolysis.This strain looks like an enterococ and therefore can certainly be missed.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd bbl¿ plate tsa 5prct sb 90mm has been found producing a false negative result.Confirmatory testing was performed.There was no report of patient impact.The following has been provided by the initial reporter: is a confirmatory test always performed? if we specifically test for gbs we add an ngm plate on which we will find it.But in normal clinical samples of f.E.Sputum we could miss it because the growth is similar to a enterococ.¿ were patient samples involved? yes.¿ were erroneous results reported to the clinician? we discovered this by chance so there is a chance of erroneous results but we can¿t confirm neither deny them.¿ were patients treated based on erroneous results? i think there is a higher chance of non-treatment because we could miss the gbs.On the tsa (254087), gbs strains grow without or with minimal hemolysis.This strain looks like an enterococ and therefore can certainly be missed.

Manufacturer Narrative

H6: investigation summary: the customer reported the strain gbs to grow without or with minimal hemolysis.The complaint history has been reviewed for a period of 12 months and no similar complaint was reported within this period for this catalog number.The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.An analysis of the growth has been performed on the retain samples from the complained batch 2088980.Following strains were tested: -streptococcus agalactiae atcc 12386 growth with good visible hemolysis.Enterococcus faecalis atcc 29212 visibility of hemolysis witihin the range results were evaluated after an incubation time between 18-24h, 36°c±1°c; co2 atmosphere.At this stage of our investigation, we have excluded any systemic failure in our production process.No deviation could be found during the qc performance test.The batch history review did reveal no deviations.Based on the evaluation of the report and based on the qc test results, the complaint was not confirmed for incorrect reaction of gbs strain.A corrective and preventive action will not be implemented as a trend could not be identified.A definite root cause could not be determined.

• Brand Name: BD BBL¿ PLATE TSA 5PRCT SB 90MM
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14634450
• MDR Text Key: 302851570
• Report Number: 9680577-2022-00071
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

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 Expiration Date: 07/06/2022
• Device Catalogue Number: 254087
• Device Lot Number: 2088980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1