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

Model Number B 101 HBA1C

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).Device requested for return but not available.

Event Description

The customer complained of questionable high hba1c results for an unknown number of patients tested on a cobas b101 instrument serial number (b)(4).The customer did not provide any specific results.The customer stated the hba1c results from the cobas b101 were higher by 0.5% or more compared to the latex immunoagglutination method.There was no allegation of an adverse event.The cobas b101 optical check test passed twice.The reagent disk was requested for return but was not available.Performance testing was performed on the cobas b101 with acceptable results.The investigation is currently ongoing.

Manufacturer Narrative

The reagent disk was provided for investigation.The investigation did not determine a discrepancy from the customer¿s material and retention material.No defect, damage or failure was found with the customer¿s instrument.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS B 101 HBA1C TEST
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8357646
• MDR Text Key: 136740369
• Report Number: 1823260-2019-00724
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K163633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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
• Device Operator: Health Professional
• Device Model Number: B 101 HBA1C
• Device Catalogue Number: 06378676190
• Device Lot Number: 831041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1