MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC BIOPLEX 2200; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS, PRODUCT CODE: NSU

Model Number	BIOPLEX 2200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bioplex 2200 is connected to inpeco laboratory automation system (tla) at (b)(6) in spain.On october 19th, 2022, bio-rad technical support received an email from the customer that a sample was added to the queue for sampling on bioplex and an error occurred.2 samples that were behind the first sample were not moved to the gating area of the bioplex, but bioplex showed samples are in process.The incident was detected by the testing laboratory and results were not reported to the patient.Additionally, we have confirmed that when the incident occurs the track line system reports a "red state" error warning which is presented at the user interface.Per the track line interface ifu (0u00000165-en-us.10), this error indicates that the communication between analyzer and automation system has been interrupted or the analyzer is in error condition.User intervention is required to recover from this error condition which renders these incidents as detectable.On october 24th, 2022, bio-rad technical support personnel escalated the case as a potential adverse event.Software engineers from inpeco and bio-rad are evaluating event logs and investigating the root cause for this issue.
Event or Problem Description
The bioplex is connected to a inpeco laboratory automation system (tla).A sample was added to the queue for sampling on bioplex and an error occurred.2 samples that were behind the first sample were not moved to the gating area of the bioplex, but bioplex showed samples are in process.The incident was detected by the testing laboratory and results were not reported to the patient.

• Brand Name: BIOPLEX 2200
• Common Device Name: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS, PRODUCT CODE: NSU
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC; 4000 alfred nobel dr; hercules CA 94547
• Manufacturer (Section G): BIO-RAD LABORATORIES, INC; 4000 alfred nobel dr; hercules CA 94547
• Manufacturer Contact: ragu muniandy ; 5500 e second st; benicia, CA 94510 ; 5107415812
• MDR Report Key: 15853697
• Report Number: 1000135116-2022-00002
• Device Sequence Number: 20102954
• Product Code: NSU
• UDI-Device Identifier: 00847865002813
• UDI-Public: 00847865002813
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: BK140112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: BIOPLEX 2200
• Device Catalogue Number: 660-0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown