MAUDE Adverse Event Report: ROCHE DIAGNOSTICS B2MG TINA-QUANT BETA2-MICROGLOBULIN; BETA-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM

Model Number	B2MG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.The issue was solved by replacement of the reagent pack.The follow up/corrective action was the reagent pack was replaced.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.Erroneous low results were generated by a cobas 6000 c (501) module.The events involved 1 patient with discrepant results for b2mg tina-quant beta2-microglobulin.The provided patient's age was (b)(6).The patient was a female.

• Brand Name: B2MG TINA-QUANT BETA2-MICROGLOBULIN
• Common Device Name: BETA-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8551517
• Report Number: 1823260-2019-90113
• Device Sequence Number: 19419679
• Product Code: JZG
• UDI-Device Identifier: 04015630900152
• UDI-Public: 04015630900152
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: No Information
• Device Model Number: B2MG
• Device Lot Number: 356659
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1