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 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.This event occurred in (b)(6).

Event Description

The initial reporter received questionable hemoglobin a1c results from cobas b 101 analyzer serial number (b)(4).Patient 1 cobas b 101 result was 8.0% and the laboratory result was 7.4%.On (b)(6) 2019, patient 2 cobas b 101 result was 5.6% and the laboratory result was 5.0%.Patient 3 cobas b 101 result was 7.3% and the laboratory result was 6.6%.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The customer¿s cobas b101 instrument (sn (b)(6)) was investigated, but no issues were found.The manufacturer batch record for cobas b101 hba1c of lot 915041-01 showed no abnormalities.Retention material of cobas b101 hba1c 915041-01 was tested with whole blood measurements and compared to target values obtained from a tosoh g8 instrument: five low, five middle, and five high whole blood samples were measured with retention material of cobas b101 hba1c lot 915041-01 on a retention cobas b101 instrument.There were no discrepant hba1c results measured with retention material hba1c disc lot 915041-01.The low range deviations were between 0.1 ¿ 0.3 % ngsp.The average deviation was 0.22% ngsp.The middle range deviations were between 0.4 - 0.5% ngsp.The average deviation was 0.42% ngsp.The high range deviations were between -0.5 ¿ -0.2% ngsp.The average deviation was -0.34% ngsp.The returned customer discs of cobas b101 hba1c of lot 915041-01 as well as retention discs of the same lot were measured with whole blood on a retention cobas b101 instrument and compared to values obtained from a tosoh g8 instrument.Seven low, seven middle, and seven high whole blood samples were measured with the customer¿s cobas b101 hba1c discs of lot 915041-01 on a retention cobas b101 instrument.The low range deviations from the customer¿s discs were between 0.2 and 0.3 % ngsp.The average deviation was 0.2% ngsp.The middle range deviations from the customer material were between 0.4 and 0.7% ngsp.The average deviation was 0.4% ngsp.The high range deviations from the customer material were between -0.3 and -0.2% ngsp.The average deviation was -0.2% ngsp.The allegation of highly deviating hba1c results on cobas b101 hba1c discs of lot 915041-01 could not be verified neither with retention material nor with the test discs that the customer has provided.The customer allegation is not substantiated, the product met specification.

• 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: 9563983
• MDR Text Key: 217641969
• Report Number: 1823260-2020-00095
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• 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: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1