MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MYO2 TINA-QUANT MYOGLOBIN GEN.2; MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM

Model Number	MYO G2
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigations are ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.These events have been attributed to a roche-initiated recall.Any future events attributed to this recall will be reported by traditional mdr.Internal investigations have confirmed customer complaints of quality control (qc) imprecision and calibration failures for the tina-quant myoglobin gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c 311 analyzer and cobas c 501 and 502 modules due to a drop in signal in the reaction kinetics.This signal drop has been traced to an adjacent cell mixing effect.Sample recovery is decreased as a consequence of the disturbance in reaction kinetics.Calibrations, qc, and patient samples can be affected.It cannot be excluded that in the worst case, calibration and qc measurements take place in cuvettes that are not subject to adjacent cell mixing while patient results are then obtained in cuvettes that are subject to random adjacent cell mixing.Roche investigations found discrepancies of up to -30%.The following issues were reported: calibration failures; dup.E error due to a signal drop in reaction kinetics.Sporadic quality control (qc) imprecision.Reagent probe extra wash cycle (ewc) must be manually programmed on the analyzer/module to prevent the adjacent cell mixing effect.In addition to programming the extra wash cycles, cobas c 501 and 502 module customers must run the tinaquant myoglobin gen.2 assay in batch mode.The total number of tina-quant myoglobin gen.2 samples that can be run at a time in batch mode must not exceed 39 samples.The cobas c 501 and 502 modules must be in stand by mode before and after the tina-quant myoglobin gen.2 batch mode run.Additionally, calibration for the tina-quant myoglobin gen.2 assay must be selected and run separately from all other assays.
Event or Problem Description
This report summarizes 2 malfunction events.Questionable non-reproducible myo2 myoglobin gen.2 results were generated by the cobas 6000 c501 module and the cobas 8000 c 502 module.The events involved a total of 2 patients.The patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.The patients' genders were requested, but were not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.

• Brand Name: MYO2 TINA-QUANT MYOGLOBIN GEN.2
• Common Device Name: MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8909904
• Report Number: 1823260-2019-90216
• Device Sequence Number: 253667
• Product Code: DDR
• UDI-Device Identifier: 04015630921294
• UDI-Public: 04015630921294
• Combination Product (Y/N): N
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• 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: MYO G2
• Device Lot Number: 349860, ASKU
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2019
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1823260-06/28/2019-006-C
• Patient Sequence Number: 1