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

Catalog Number 08038694190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer does not have any more reagent discs to return.

Event Description

The customer complained of discrepant results for 1 patient tested for cobas hba1c test (hba1c) on a cobas b 101 system.The date of event was either (b)(6) 2018.Clarification on the correct date has been requested but not yet provided.The patient was tested on the b 101 system at approximately 11:30 a.M.And the result was 11.8% (106 mmol/mol).Blood was drawn for a laboratory test on the same day and the result from the bio-rad d-100 method was 13.5% (124 mmol/mol).There was no allegation that an adverse event occurred.The b 101 instrument serial number was (b)(4).Qc results were acceptable.The bio-rad method is an ion exchange high performance liquid chromatography test.The b 101 system and the d-100 bio-rad method do not use the same reference method.Systems using different reference methods can produce different results.The customer does not have any reagent discs from the hba1c lot number complained about to return.Retention material lot number 816041 was tested on a retention cobas b 101 instrument.All the results obtained were within the specification.No discrepancies or incorrect results were observed with the retention material.

Manufacturer Narrative

The date of event was clarified to be (b)(6) 2018.

Manufacturer Narrative

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: 7865519
• MDR Text Key: 119943677
• Report Number: 1823260-2018-03068
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 07613336119778
• UDI-Public: 7613336119778
• 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,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08038694190
• Device Lot Number: 816041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED INSULIN
• Patient Age: 42 YR
• Patient Weight: 90