MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA READA COMPACT; NOT CLASSIFIED

Model Number	447206
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd kiestra reada compact that there was contamination.The following information was provided by the initial reporter: during the reading customer found that there is 3 dishes that has mold on it.Customer gave the dishes number to proceed to find all the locations that were on the rc.Customer proceed to decontaminate all the areas when this dishes were.Customer is also complaining that this rc3 has a lot humidity and bad smell.Customer is asking from complete check of this rc and asking decontamination procedure.For now customer will check plate by plate to ensure that there is no mold on it.Issue description: customer reports that find mold in the rc3 in 3 dishes in rc3.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6.Investigation summary: the customer reported on the reada compact material number: (b)(4) serial number: (b)(6).It was reported by the customer that 3 dishes that has mold on it and rc3 has a lot of humidity and bad smell.Bd technical services recommended that the customer perform the required maintenance to clean the incubator.A field service engineer (fse) went onsite and replaced the hepa filter.After this, the issue has been resolved and now the instrument is back to routine use.The complaint is confirmed.No new trends, risks, or hazards were identified as a result of this complaint.No patient impact was reported as part of this complaint.Device history record (dhr) review is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Bd quality will continue to closely monitor for trends associated with this issue.H3 other text : see h10.
Event or Problem Description
It was reported that while using the bd kiestra reada compact that there was contamination.The following information was provided by the initial reporter: ¿ during the reading customer found that there is 3 dishes that has mold on it.¿ customer gave the dishes number to proceed to find all the locations that were on the rc.¿ customer proceed to decontaminate all the areas when this dishes were.¿ customer is also complaining that this rc3 has a lot humidity and bad smell.¿ customer is asking from complete check of this rc and asking decontamination procedure.¿ for now customer will check plate by plate to ensure that there is no mold on it.R 2.Issue description: customer reports that find mold in the rc3 in 3 dishes in rc3.

• Brand Name: BD KIESTRA READA COMPACT
• Common Device Name: NOT CLASSIFIED
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16748648
• Report Number: 3010141591-2023-00002
• Device Sequence Number: 8556486
• Product Code: JTQ
• UDI-Device Identifier: 00382904472061
• UDI-Public: 00382904472061
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Other
• Device Model Number: 447206
• Device Catalogue Number: 447206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown