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

Model Number 443812

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

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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 was reported that while using kit bd max ext enteric bacterial panel false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "in run 4699 a12 there is a positive outcome for vibrio bd max ct2261.".

Manufacturer Narrative

This mdr should be considered cancelled.This issue was with the instrument and not the reagent.An mdr for the instrument malfunction was filed under mfr report number: 1119779-2021-01240.

Event Description

It was reported that while using kit bd max ext enteric bacterial panel false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " in run 4699 a12 there is a positive outcome for vibrio bd max ct2261.".

Manufacturer Narrative

The following batch information was provided as additional information for this report: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 0197944.D.4.Medical device expiration date: 2022-01-29.H.4.Device manufacture date: 2020-07-21.D.4.Medical device lot #: 0016210.D.4.Medical device expiration date: 2021-07-31.H.4.Device manufacture date: 2020-01-30.

Event Description

It was reported that while using kit bd max ext enteric bacterial panel false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " in run 4699 a12 there is a positive outcome for vibrio bd max ct2261.".

• Brand Name: KIT BD MAX EXT ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 12197309
• MDR Text Key: 266716868
• Report Number: 3007420875-2021-00039
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: 00382904438128
• Combination Product (y/n): N
• PMA/PMN Number: K170308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2021

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 Model Number: 443812
• Device Catalogue Number: 443812
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 06/21/2021
• Supplement Dates FDA Received: 09/03/2021; 09/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1