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 Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for three patient samples 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 samples were repeated and the repeat measurements matched the clinical condition and previous results of the patients.The reporter also mentioned that they recently receive frequent errors on the cobas b 101 instrument.The first sample initially resulted with an hba1c value of 8.4 %, which repeated as 7.4 %.Both measurements were performed using hba1c test disc lot 929042-01.The second sample initially resulted with an hba1c value of 6.6 %, which repeated as 6.0 %.Both measurements were performed on (b)(6) 2019 using hba1c test disc lot 929042-01.The third sample initially resulted with an hba1c value of 6.5 % when measured using hba1c test disc lot 929042-01 on (b)(6) 2019.The sample was repeated on (b)(6) 2019 using hba1c test disc lot 930041-01, resulting with a value of 5.5 %.

Manufacturer Narrative

Retention cobas b101 hba1c test disc lot 929042-01 and lot 930041-01 were investigated.The manufacturer batch record for cobas b101 hba1c test disc lot 929042-01 and lot 930041-01 showed no abnormalities.The manufacturer final product inspection report for cobas b101 hba1c test disc lot 929042-01 and lot 930041-01 showed no abnormalities and all features passed.Retention discs cobas b101 hba1c disc lot 929042-01 and lot 930041-01 were measured with blood compared to reference method: 4 replicates 6 replicates at 2 levels (whole blood low and middle): 4 whole blood "low" samples were tested with discs retention material hba1c lot 929042-01 with retention phc cobas b101 instrument.Results did not show the difference which the customer is claiming.4 whole blood "middle" samples were tested with discs retention material hba1c lot 929042-01 with retention phc cobas b101 instrument.Results did not show the difference which the customer is claiming.6 whole blood "low" samples were tested with discs retention material hba1c lot 930041-01 with retention phc cobas b101 instrument.Results did not show the difference which the customer is claiming.6 whole blood "middle" samples were tested with discs retention material hba1c lot 930041-01 with retention phc cobas b101 instrument.Results did not show the difference which the customer is claiming.There were no discrepant hba1c results measured with retention material hba1c disc lot 929042-01 and lot 930041-01.Discrepant hba1c results could not be confirmed.The provided customer data showed data deviation between 1st and 2nd measurement was 0.6-1.0% ngsp on hba1c lot 929042-01.- retention material data showed data deviation between 1st and 2nd measurement was 0-0.1% ngsp on hba1c lot 929042-01.- retention material testing: data deviation between hba1c test disc lot 929042-01 and lot 930041-01 is 0.1% ngsp.The provided customer's data deviation was 1.0%ngsp.- the investigation showed that the measurement data obtained with retention material has no deviation like the customer complained about.Upon review of the instrument's data logs, a warning message occurred at the same time the complained measurements were performed for the first sample.The message indicates abnormally high hemoglobin.This message occurs if the b101 instrument detects that the hemoglobin concentration in the tested blood sample is over the measureable range (20g/dl).The message can also occur if the blood sample entered into the disc through the inadequate portion (hole).The message can also occur if the sample volume is too much when the sample is overflowed from the capillary channel due to the impact such as a drop, the hemoglobin concentration is over the measurable range.The same warning message occurred many times between (b)(6) 2019 and (b)(6) 2019.

• 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: 9152603
• MDR Text Key: 217081925
• Report Number: 1823260-2019-03562
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: 08038694190
• Device Lot Number: 929042-01
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1