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

Catalog Number 06378676190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained of discrepant results for 1 patient tested for hemoglobin a1c (hba1c) on the cobas b 101 instrument.The initial result from the patient's middle finger was 5.8%.The patient was re-tested immediately using the index finger and the result was 6.4 %.The result of 6.4% was provided to the patient.It is not clear which result was believed to be correct.There was no allegation that an adverse event occurred.The b 101 instrument serial number was (b)(4).Calibration and qc has not been performed for over 6 months.An optical check has not been performed for over 6 months.

Manufacturer Narrative

The customer did not return any product.Testing was performed using retention disc lot 730043-01 at the manufacturer.12 blood samples were tested on the b 101 hba1c disc compared to the tosoh g8 internal reference method.No discrepant results were obtained.All obtained results were acceptable and meet specification.The error log file from the instrument was reviewed where an e-236 error occurred twice and an e-300 error occurred 6 times.These errors indicate that the hba1c disc was not sitting properly within the b 101 instrument.The instrument may be damaged due to a handling issue with the disc.The investigation was unable to find a definitive root cause.

• 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: 7341221
• MDR Text Key: 103149730
• Report Number: 1823260-2018-00838
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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: 730043-011
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1