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

Model Number B 101 HBA1C

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

The hba1c retention reagent lot 834041-01 was measured with blood compared to the reference method with three levels of whole blood.The results were acceptable.The suspect device was requested to be returned for investigation.The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable results for 1 patient tested for the cobas hba1c test on a cobas b 101 instrument compared to the results from an external laboratory.The laboratory method was not known.The cobas b 101 instrument serial number was (b)(4).On approximately (b)(6) 2019 the absolute difference between the hba1c result on the b101 and the external laboratory with venous blood was 0.8%.The specific date and results were asked for but not provided.It was asked but not known if the questionable result were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause 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: 8827700
• MDR Text Key: 152667021
• Report Number: 1823260-2019-02713
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B 101 HBA1C
• Device Catalogue Number: 08038694190
• Device Lot Number: 834041-01
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1