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

Model Number B 101 HBA1C

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device was requested to be returned for investigation.The investigation is ongoing.

Event Description

The initial reporter complained of questionable results for 1 patient tested for cobas hba1c test on a cobas b 101 instrument compared to the results from an external laboratory.The hba1c result from the b 101 was 5.7% (39 mmol/mol) and the hba1c result from the laboratory with venous blood was 6.5% (47 mmol/mol).On (b)(6) 2019 the hba1c result from the b 101 was 7.1% (54 mmol/mol) and the hba1c result from the laboratory was 6.5% (47 mmol/mo).There was no allegation of an adverse event.

Manufacturer Narrative

The customer did not return any materials for investigation.The customer did not provided the respective lot numbers used.Without these materials to investigate, a specific root cause could not be determined.

Manufacturer Narrative

The customer provided the hba1c reagent lot number and expiration date.Medwatch field model #, serial #, expiration date, catalog #, lot #, other #, udi #.Was updated.

• 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: 8798164
• MDR Text Key: 151318131
• Report Number: 1823260-2019-02634
• 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,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: B 101 HBA1C
• Device Catalogue Number: 06378676190
• Device Lot Number: 835041-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1