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 09/07/2019

Event Type  malfunction  

Manufacturer Narrative

The customer ran an optical check on the instrument and this passed.This event occurred in (b)(6).

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with the cobas b 101 hba1c test on cobas b 101 instrument serial number (b)(4).It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The sample resulted with an hba1c value of 6.9 % when tested on the cobas b 101 instrument.The sample was sent to another laboratory for testing with an unknown method, resulting with an hba1c value of 6.2 %.The result of 6.2 % matched the patient's clinical condition.

Manufacturer Narrative

The manufacturer batch record for cobas b101 hba1c of lot 915041-01 showed no abnormalities.The manufacturer final product inspection report for cobas b101 hba1c test discs of lot 915041-01 showed no abnormalities and all features passed.Retention material of cobas b101 hba1c lot 915041-01 was tested with whole blood measurements and held against target values obtained from a tosoh g8 instrument: a) fourteen "low" whole blood samples were measured with retention material of cobas b101 hba1c lot 915041-01 a retention cobas b101 instrument.B) fourteen "middle" whole blood samples were measured with retention material of cobas b101 hba1c lot 915041-01 a retention cobas b101 instrument.C) fourteen "high" whole blood samples were measured with retention material of cobas b101 hba1c lot 915041-01 a retention cobas b101 instrument.Results: there were no discrepant hba1c results measured with retention material hba1c disc lot 915041-01.Discrepant hba1c results could not be confirmed.A) low range deviations were between -0.1 ¿ 0.3 % ngsp.The average deviation was 0.1% ngsp.B) middle range deviations were between 0.1 - 0.4% ngsp.The average deviation was 0.3% ngsp.C) high range deviations were between -0.4 ¿ 0% ngsp.The average deviation was -0.2% ngsp.There was no data deviation measured with retention material of cobas b 101 hba1c discs of lot 835041-01 on a retention phc cobas b101 instrument.All obtained results are acceptable and meet specifications.Discrepant hba1c results could not be confirmed.Low range deviations was 0.0 - 0.2% ngsp.The average deviation is 0.12% ngsp.Middle range deviations was 0.1 - 0.4% ngsp.The average deviation is 0.25% ngsp.High range deviations were between -0.4 ¿ 0% ngsp.The average deviation was -0.2% ngsp.The error and audit trail logs that the customer provided were analyzed and contained warnings and errors which are not indicative of potential result deviations.There were several error messages indicating that the instrument detected an error related to the sample volume or condition during an hba1c measurement.There was a log entry message which indicated that the ambient temperature measured by the cobas b 101 instrument was outside of the normal operating temperature.Further errors were observed indicating there were reagent disc handling issues in which the disc was not put in the instrument correctly.The instrument is 6 years old and does not contain the latest firmware.

• 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: 9123282
• MDR Text Key: 216919768
• Report Number: 1823260-2019-03457
• 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,u
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: B 101 HBA1C
• Device Catalogue Number: 08038694190
• Device Lot Number: 915041-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1