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 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's meter was tested with qc material.Level 1: pass, 5.1%, range 4.3-6.5.Level 2: pass, 8.6%, range 7.4-11.2.This event occurred in (b)(6).

Event Description

The initial reporter received a questionable hemoglobin a1c result for one patient sample from the cobas b 101 instrument serial number (b)(4).The result from the b101 was 7.1 %.The result from another laboratory using an unknown method was 6.4 %.It was not known if any questionable result was reported outside of the laboratory.

Manufacturer Narrative

Retention material of cobas b101 hba1c test discs of lot 931043-01 was tested and no discrepant hba1c results were received.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: 9446524
• MDR Text Key: 206514502
• Report Number: 1823260-2019-04365
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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: 06378676190
• Device Lot Number: 931043-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR