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

Catalog Number 06378676190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of questionable low hba1c results for 2 patient samples tested on a cobas b 101 instrument with serial number (b)(4) compared to an external laboratory method of hitachi clinical analyzer m40.The customer stated that the cobas b101 hba1c results tend to be about 1% lower than the hitachi m40 and is mainly prevalent in diabetic patients.For patient 1 the hba1c result from the cobas b101 was 7.3%.The result from the hitachi m40 was 8.7% for patient 2 the hba1c result from the cobas b101 was 5.5%.The result from the hitachi m40 was 6.7% the erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The cobas b101 optical checks passed.Qc results using a relevant retention lot were acceptable.The hba1c disc used by the customer has been requested for further investigation.The investigation is currently ongoing.

Manufacturer Narrative

The customer did not return any products for investigation.Five venous blood samples were tested with discs from each of the four retention batches from lot 828041-01.20 measurements in total were compared to the results form a cobas c501 and no discrepant results were obtained.All obtained results were acceptable and met specification.Review of the error log from the instrument showed no errors related to the discrepant results.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: 7923191
• MDR Text Key: 123829158
• Report Number: 1823260-2018-03377
• 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: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06378676190
• Device Lot Number: 82804101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1