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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

For one of the events, the issue observed by the customer could be reproduced, but the cause can only be explained by a mishandling of the customer.A dent on the bearing plate of one cobas b 101 system was observed, causing an unstable rotation of the plate.Errors indicate that the bearing plate damage was caused by the reagent disk being set incorrectly in the analyzer.For one of the events, the investigation determined that performance testing was performed on the cobas b101 with acceptable results.The investigation did not identify a product problem.The cause of the event could not be determined.There were no follow up/corrective actions.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events.Erroneous non-reproducible results were generated by cobas b 101 instruments.One event involved 1 patient and the other event involved an unknown number of patients with discrepant results for hba1c.

• 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: 8551523
• MDR Text Key: 143408866
• Report Number: 1823260-2019-90102
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Number of Events Reported: 2
• 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: 04/25/2019
• 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: 831041, 819041
• Type of Device Usage: N
• Patient Sequence Number: 1