MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 101 HBA1C TEST; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number B 101 HBA1C

Device Problem Non Reproducible Results (4029)

Patient Problem Test Result (2695)

Event Type  malfunction  

Manufacturer Narrative

The investigations found that there was no indication of a product problem.The customer did not require or request further investigation.The investigation did not identify a product problem.The cause of the event could not be determined.There were no followup/corrective actions taken.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Erroneous non-reproducible results were generated by the cobas b 101 analyzer.The events involved 1 patient with erroneous hemoglobin a1c results.The patient's age was requested but was not provided.The patient's weight was requested but was not provided.The patient's gender was requested but was not provided.The patient's gender was requested but was not provided.The patients' ethnicity was requested but was not provided.

• Brand Name: COBAS B 101 HBA1C TEST
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8281633
• MDR Text Key: 134367935
• Report Number: 1823260-2019-90018
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630930616
• UDI-Public: 4015630930616
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: B 101 HBA1C
• Device Lot Number: ASKU
• Type of Device Usage: N
• Patient Sequence Number: 1