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 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable result hemoglobin a1c results for three patient samples from cobas b 101 instrument serial number (b)(4).The samples were repeated in another laboratory with an unknown method.Patient 1: b101 result was 7.9% and the repeat result was 7.2%.Patient 2: b101 result was 7.3% and the repeat result was 6.5%.Patient 3: b101 result was 8.3% and the repeat result was 7.4%.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.Retention material of cobas b101 hba1c lot 931043-01 was tested with whole blood measurements and held against target values obtained from a tosoh g8 instrument: a) eight low whole blood samples were measured with retention material of cobas b101 hba1c lot 931043-01 on a retention cobas b101 instrument.B) eight middle whole blood samples were measured with retention material of cobas b101 hba1c lot 931043-01 on a retention cobas b101 instrument.The product meets specification.Retention material testing and manufacturer final product inspection were successful.The retention material measurements on the retention cobas b101 instrument showed no hba1c deviation compared to tosoh g8.

• 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: 9429521
• MDR Text Key: 218729623
• Report Number: 1823260-2019-04302
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 931043-012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1