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 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect product was requested to be returned for investigation.This event occurred in (b)(6).

Event Description

The initial reporter received questionable hemoglobin a1c results for an unknown number of patient samples from cobas b101 analyzer.The serial number was requested but was not provided.Data was provided for four patient samples.Patient 1 b101 result was 6.5% and the repeat result was 5.9%.On (b)(6) 2019, patient 2 b101 result was 7.5% and the repeat result was 6.7%.On (b)(6) 2019, patient 3 b101 result was 7.7% and the repeat result was 7.1%.On (b)(6) 2019, patient 4 b101 result was 8.1% and the repeat result was 7.4%.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

The customer returned 10 unused discs of cobas b101 hba1c test discs for investigation.The batch records of the lot were reviewed and showed no abnormalities and all features passed.The log files from the instrument were provided, but did not contain errors.Retention material and the customer returned material were tested and no discrepant hba1c results were seen.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: 9412343
• MDR Text Key: 214341604
• Report Number: 1823260-2019-04253
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• 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: 91504101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR