MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA (800) HBA1CDX GEN 2; ASSAY, GLYCOSYLATED HEMOGLOBIN

Catalog Number 04528123160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that from (b)(6) 2017, they had been having trouble keeping quality controls in range for the a1c-2 tina-quant hemoglobin a1c gen.2 (hba1c) test on the cobas integra 800 (i800).The customer tried calibrating and using fresh controls, but the issue was not resolved.The customer also mentioned that they received a complaint from a doctor stating that there were issues with an unspecified number of patient results that were reported outside of the laboratory.Patients were being diagnosed incorrectly for diabetes.The customer could not provide specific patient data, but stated that results for approximately 40 samples needed to be corrected because the difference in initial and repeat values was 0.8 - 1.0 %.No patients were treated based on erroneous results.The patients were not adversely affected.The i800 analyzer serial number was (b)(4).The customer stated that the issue was caused by an operator handling issue.The reagent, calibrator, and deproteinizer were incorrectly handled by the operator and control ranges were incorrect.There were no issues with the analyzer.No further details were provided.The customer stated that the issue is now resolved.

Manufacturer Narrative

The issue was determined to be caused by the incorrect handling of the reagent, calibrator, deproteinizer, and control material.There was no issue with the analyzer or performance of the materials.

• Brand Name: COBAS INTEGRA (800) HBA1CDX GEN 2
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7199166
• MDR Text Key: 98012433
• Report Number: 1823260-2018-00153
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 04528123160
• Device Lot Number: 25531601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1