MAUDE Adverse Event Report: BIO-RAD LABORATORIES INC. D-10 HEMOGLOBIN TESTING SYSTEM ; GLYCOSYLATED HEMOGLOBIN ASSAY

Catalog Number 2200261

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a laboratory personnel from (b)(4) indicated that a physician had questioned a patient's a1c result obtained on the d-10 hemoglobin testing system.(b)(4) confirmed there were no indications from the physician of any change of treatment or harm done to any patients based on the erroneous a1c result.(b)(4) stopped running the d-10 instrument on (b)(6) 2015.(b)(4) personnel said that they did a comparison for patient samples for the past 3 days (11, 12, 13) with results obtained from another lab.All patient results that were over 10% discrepancy tolerance were reported to the physician.(b)(4) personnel reported that 4 patients exceeded the 10% tolerance.The rest of the results matched the results they had obtained in their own lab.(b)(4) also confirmed that no patient samples were run since they reported the issue on (b)(6) 2015 until after the issue was resolved on (b)(6) 2015.

Manufacturer Narrative

An investigation is underway to determine root cause for the incident.

Manufacturer Narrative

A field service engineer was able to resolve the issue by replacing the detector.The detector has not been returned for analysis.A root cause has not been confirmed.Note: catalog number has been changed to reflect a detector part number, rather than that the overall testing system number.

• Brand Name: D-10 HEMOGLOBIN TESTING SYSTEM
• Type of Device: GLYCOSYLATED HEMOGLOBIN ASSAY
• Manufacturer (Section D): BIO-RAD LABORATORIES INC.; 4000 alfred nobel dr.; hercules CA 94547
• Manufacturer Contact: nishi singh ; 4000 alfred nobel dr.; hercules, CA 94547 ; 5107416114
• MDR Report Key: 4602508
• MDR Text Key: 5468902
• Report Number: 2915274-2015-00008
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2200261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1