MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) KIT BD MAX EXT ENTERIC BACTERIAL PANEL; GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Model Number 442963

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It was reported by the customer that several bd max¿ enteric bacterial panel reported false positive.There was one occurrence in this event and there was no patient impact.The following information was provided by the initial reporter: "customer reports several vibrio fps when using 442963 - lot numbers: 2018217 and 1243582.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results with the bd max¿ extended enteric bacterial panel kit (xebp) (ref.(b)(4) lots 0352298, 1048107, 1104039, 1202533 and 1328353 was performed by the review of the manufacturing records, review of customer¿s data and verification of complaints history.Review of the manufacturing records of bd max¿ extended enteric bacterial panel kit indicated that lots 0352298, 1048107, 1104039, 1202533 and 1328353 were manufactured according to specifications and met performance requirements.Customer complained about false vibrio positive results with the bd max¿ xebp assay.Customer provided a document describing the samples for which the customer suspected vibrio false positive results.However, this list differed from the samples described in the complaint text.Only the list of samples in the complaint text was analyzed (runs 1216, 1343, 1476, 1590, 1597, 1645, 2149, 2209, 2338, 2356, 2379, 2382, 2421, 2555, 2557, 2565 and 2614).Preliminary analysis of the runs revealed a potential instrument issue.After review of the customer data by a bd instrument quality engineer, an instrument issue was suspected of being linked to the vibrio false positive results.An instrument service ticket was opened to assess a potential pipettor/pump issue on instrument ct1564.Moreover, some of the vibrio false positive results could be attributable to contamination, after some evidence of contamination was found by the customer during additional environmental monitoring tests.Based on the information provided and investigation results, bd was unable to confirm the exact cause of the customer¿s positive results, but overall, no reagents issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ extended enteric bacterial panel kit lots 0352298, 1048107, 1104039, 1202533 and 1328353.The root cause was not identified.However, an instrument issue and an environmental/cross contamination issue can explain the customer¿s positive results.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action plan (capa).Bd quality will continue to monitor for trends.H3 other text : see h.10.

Event Description

It was reported by the customer that several kit bd max ext enteric bacterial panel reported false positives.There was one occurrence in this event and there was no patient impact.The following information was provided by the initial reporter: "customer reports several vibrio fps when using (b)(4) - lot numbers 0352298, 1048107, 1104039, 1202533, 1328353.".

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 0352298 medical device expiration date: 16-jul-2022 device manufacture date: 07-jan-2021 medical device lot #: 1048107 medical device expiration date: 03-sept-2022 device manufacture date: 18-feb-2021 medical device lot #: 1104039 medical device expiration date: 26-oct-2022 device manufacture date: 22-apr-2021 medical device lot #: 1202533 medical device expiration date: 25-feb-2023 device manufacture date: 15-sept-2021 medical device lot #: 1328353 medical device expiration date: 10-jun-2023 device manufacture date: 01-dec-2021 the following fields were updated due to corrected information: describe event: it was reported by the customer that several kit bd max ext enteric bacterial panel reported false positives.There was one occurrence in this event and there was no patient impact.The following information was provided by the initial reporter: "customer reports several vibrio fps when using 443812 - lot numbers 0352298, 1048107, 1104039, 1202533, 1328353." medical device brand name: kit bd max ext enteric bacterial panel medical device type: pch medical device catalog #: 443812 unique identifier: (b)(4).510k number: k170308.

Event Description

It was reported by the customer that several kit bd max ext enteric bacterial panel reported false positives.There was one occurrence in this event and there was no patient impact.The following information was provided by the initial reporter: "customer reports several vibrio fps when using 443812 - lot numbers 0352298, 1048107, 1104039, 1202533, 1328353.".

• Brand Name: KIT BD MAX EXT ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14758221
• MDR Text Key: 303094070
• Report Number: 3007420875-2022-00033
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: 00382904438128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

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: 01/28/2023
• Device Model Number: 442963
• Device Catalogue Number: 443812
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 09/14/2022; 09/20/2022
• Supplement Dates FDA Received: 09/19/2022; 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1