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

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	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bioplex 2200 is connected to inpeco laboratory automation system (tla) at (b)(6) in norway.On sept 15th, 2022, a request came from (b)(4)(distributor of the inpeco tla in norway) to access the communication logs between bioplex and tla because of an error at the aspiration position of the tla, a sample tube became stuck in the track line at the bioplex gating area.The bioplex pipetted from the tube several times and misassigned the sample to subsequent accession numbers.(b)(4) has confirmed that the incident was detected by the testing laboratory and results were not reported.The laboratory retested the samples without recurrence of incident.On september 19th, 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).Due to an error at the aspiration position of the tla, a sample tube became stuck in the track line at the bioplex gating area.The bioplex pipetted from the tube several times and misassigned the sample to subsequent accession numbers.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
• 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: 15629585
• Report Number: 1000135116-2022-00001
• Device Sequence Number: 5983130
• Product Code: NSU
• UDI-Device Identifier: 00847865002813
• UDI-Public: 00847865002813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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